FDA Consumer, July-August 2006 · India, follows the expiration of GlaxoSmithKline's patent on its capsule form of the product marketed under the trade name Retrovir. "This is a signiﬁcant

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a t i o

Mike Leavi t t

Secretary of Health and Human Services

Andrew C. von Eschenbach, M.O.Acting Commissioner of Food and Drugs

Jason D. BrodskyAssistant Commissioner for ExternalRelations

Raymond Formanek Jr. / Editor

Michael Ermarth / Art Director

Linda Bren, Michelle Meadows,Carol Rados / Staff Writers

Lisa Latimer / Production Assistant

Cover; Corhis

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YDkConsumerThe Magazine of the U.S. Food and Drug Administration

July-August 2006 • Vol. 40 No. 4

8 Getting Ready for Another Flu SeasonMore vaccine should be available for the 2006-2007 season, and

experts have prepared new recommendations for who should getflu shots .

1 0 A F o c u s o n V i s i o n

Surgical developments and advances in corrective eyewear providemany options for improving vision.

18 Some Cold Medicines Move Behind CounterFind out why you may have to show your ID to a pharmacist to buyover-the-counter decongestants.

Cover Story20 Med ica t ion Use and O lder Adu l t s

Older adults, their family members, and caregivers can partner withhealth professionals to improve medication management.

27 Artificial Sweeteners: No Calories ... Sweet!Here's a tasty look at the artificial sweeteners approved by the FDA.

29 The FDA Approves New Drug for Smoking CessationChantix acts at sites in the brain affected by nicotine.

30 Protecting the Public Health: More Than a Full-Time Jobfor Many at the FDAFrom doing dental work in El Salvador in 90-degree heat to trackingmissing persons in Maryland on horseback, FDA employees continueto make a difference outside of their regular workdays.

8 Manu fac tu re r s es t ima te t ha t be tween 100 m i l l i onand 120 million doses of flu vaccine will beproduced for the season ahead.

18 Some cold medicines are now behind pharmacycounters as part of the war on illegal drugs.

27 Artificial sweeteners can help reduce caloriesand aid in the management of diabetes.

30 Many FDA employees promote public health involunteer activities outside of their regular jobs.

FDA Consumer / July-August 2006 /1

D E P A R T M E N T S

2 O b s e r v a t i o n s

2 U p d a t e s

39 Investigatbrs' Reports

40 FDA Consumer Quiz

Observat ions

The risks of high blood pressure,heart disease, arthritis, and diabetesincrease with age. So do the numbero f m e d i c a t i o n s t h a t A m e r i c a n s u s e

t o t r e a t t h e s e c o n d i t i o n s . A n e s t imated 25 percent of Americans takethree or more medications each day,according to The Graying of America:An Encyclopedia of Aging, Health,Mind, and Behavior, by Donald H.Kausler and Barry C. Kausler.

In addition, the percentage of people taking multipleprescription drugs increases after age 65. For example, aMedicare beneficiary with drug coverage filled an averageof 19 drug prescriptions annually in 1999, according to theNational Institute for Health Care Management.

Of course, taking a drug exactly as prescribed is criticalto its safety and effectiveness. For example, an antibioticstopped prematurely because a person feels better couldallow an infection to recur with bacteria resistant to thedrug. Taking a drug at the wrong time, taking the wrong dosage, or forgetting to take a drug altogether could cause serious problems or limit the effectiveness of the treatment.

A variety of alarms, labeled trays, blister packs, and otheraids are available to help ensure that older people who havetrouble tracking their medicines take them as prescribed.For more on the importance of taking drugs properly andfor some strategies on how to do so, see our cover storytitled "Medication Use and Older Adults," beginning onpage 20.

Optical defects that cause light to not focus properly onthe retina of the eye cause refractive errors—one of the mostfrequent eye problems in the United States, according to the

National Eye Institute (NEI).The two most common refractive errors are nearsight

edness (myopia) and farsightedness (hyperopia). Peoplewho are nearsighted see close objects clearly, but distantobjects are blurred. It's just the reverse for those who arefarsighted—nearby objects are blurry, while distant objectsare sharp.

Other refractive errors include uneven focus (astigmatism) and an age-related problem with focusing on nearobjects called presbyopia. Researchers aren't sure why refractive errors develop, according to the NEI, but treatmentsrange from glasses and contact lenses to specially designedlasers that reshape the cornea, changing its focusing power.For more on vision correction, including the latest on FDA-approved products, read our feature article titled "A Focuson Vision," beginning on page 10.

Like others nationwide, many FDA employees don't stopworking when they leave their job for the day. Some volunteer. Some coach. Others use their expertise and passionto help people in need. We take a look at six dedicated FDAemployees who continue to make a difference outside oftheir regular job in our feature story titled "Protecting thePublic Health; More Than a Full-Time Job for Many at theFDA," beginning on page 30.

We also take a look at the preparations being made forthe upcoming flu season, the reasons why some cold medicines have been moved behind the pharmacy counter, andan update on artificial sweeteners.

Raymond Forrnanek Jr.E d i t o r

Updates

New Drug Helps Prevent HeartTransplant Rejection

A new drug that suppresses the body'simmune reaction for the prevention ofgraft rejection in heart transplant recipients has been approved by the FDA.

Prograf (tacrolimus), available incapsule form and as an injectable, waspreviously approved for the preventionof graft rejection in people receivingliver and kidney transplants. Prografacts by a mechanism similar to cyclo-sporine, another immunosuppressantused to prevent transplant rejection.

2 / FDA Consumer / Juiy-August 2006

Prograf offers an alternative to cyclo-sporine for use in certain combinationimmunosuppressive regimens in liver,kidney, and heart transplantation.

"This approval is another exampleof the benefits of our agency's 'orphan'drugs program," says Steven Galson,M.D., director of the FDA's Center forDrug Evaluation and Research, "whichseeks to answer the medical needs ofsmall groups of patients."

In a U.S. study, patient and graft survival at 12 months after transplantation in the Prograf group was similar

to that of the cyclosporine group.The use of Prograf is associated with

increased risk of neurotoxicity, renalfunction impairment, infection, andpost-transplant diabetes mellitus. Likemost combination drugs used in organtransplants, the Prograf-based combin a t i o n i s a s s o c i a t e d w i t h a n i n c r e a s e drisk of malignancies, especially non-melanoma skin cancers. Prograf ismanufactured by Astellas Pharma USInc., Deerfield, 111.

Updates

Generic Capsule Formof HIV/AIDS Drug

The FDA has approved the firstgeneric capsule dosage form of zidovudine to treat HIV/AIDS to be marketedin the United States. The tablet and oralsolution forms of zidovudine were previously approved for sale in the UnitedStates when the patent on those dosageforms expired in September 2005.

The approval of the capsule form ofthe drug, which is manufactured byAurobindo Pharma Ltd. in Hyderabad,India, follows the expiration ofGlaxoSmithKline's patent on its capsuleform of the product marketed undert h e t r a d e n a m e R e t r o v i r.

"This is a significant genericapproval," says Acting Commissionerof Food and Drugs Andrew C. vonEschenbach, M.D. "Retrovir, whichwas initially approved in March 1987,was the first of a group of breakthroughmed ica t i ons tha t have t rans fo rmedwhat was then a disease with a verydismal prognosis into one with a muchmore hopeful prognosis. Approval ofthis additional dosage form of zidovudine should help reduce the cost of this

therapy for American patients."Zidovudine is in the class of drugs

called nucleoside reverse transcriptaseinhibitors, which help keep the AIDSvirus from reproducing. This anti-ret-roviral drug is intended to be usedwith other anti-retroviral agents for thetreatment of HlV-1 infection.

H u m a n i t a r i a n D e v i c e T r e a t sRare Twin Syndrome

The FDA has approved a Humanitarian Device Exemption (HDE) forFetoscopy Instrument Sets used to treatfetuses with a rare disorder of the placenta, called twin-to-twin transfusionsyndrome (TTTS), underthe Humanitarian Use Device (HUD) program.

TTTS sometimes occurs when womenare pregnant with identical twins. During development, blood vessels in thefetuses' shared placenta connect theirblood circulations. In most cases, theblood flows properly through thesevessels. In TTTS, however, the bloodbegins to flow unevenly, with one fetaltwin receiving too much blood (therecipient) and one receiving too little(the donor). This condition can cause

heart failure in the recipient twin andlife-threatening anemia in the donortwin. Many of these TTTS babies donot survive delivery or are born withsevere handicaps.

The Fetoscopy Instrument Sets givedoctors a new option for treating TTTS,and can help prolong the mother's pregnancy and improve the odds of survivalfor both twins. Complications also arereduced fo r one o r bo th tw ins .

T h e i n s t r u m e n t s e t s a r e i n t e n d e dt o b e u s e d f o r t h e t r e a t m e n t o f T T T Sfor fetuses whose gestational age isbetween 16 weeks and 26 weeks. Thesets consist of a telescopic camera usedto view a fetus (fetoscope) and sheathsthat are used to pass other surgicalinstruments and fluid through theentry site.

The HUD program encouragesthe development of medical devicesintended to treat or diagnose a disease or condition affecting fewer than4,000 people in the United States ayear. To receive approval of an FIDEapplication, a sponsor must demonstrate the safety and probable benefitof a dev ice.

First Treatment for Pompe Disease

The FDA has approved a biologies license application(BLA) forMyozyme (alglucosidase alfa, rhCAA), the firsttreatment approved for people with Pompe disease, arare but severely debilitating disease that affects between40,000 and 300,000 Americans.

Pompe disease is inherited and caused by the deficiency or lack of the enzyme acid alpha-glucosidase,which is essential for normal muscle development andfunction. The disease drastically reduces a person's muscle and respiratory function, and usually results in deathfrom respiratory failure. Pompe disease is rapidly fatali n n e w b o r n b a b i e s .

Myozyme had been granted orphan drug designationby the FDA and was approved under a priority review.Orphan products are developed to treat rare diseases orconditions that affect fewer than 200,000 people in theUnited States. The Orphan Drug Act provides a seven-year period of exclusive marketing to the first sponsor who obtains marketing approval for a designated

orphan drug.The FDA approved Myozyme for administration by

intravenous infusion of solution into a vein. The safetyand efficacy of Myozyme were assessed in two separateclinical trials in 39 infantile-onset patients with Pompedisease ranging in age from 1 month to 3.5 years at thetime of the first infusion.

Patient survival without needing invasive ventilatorysupport was substantially greater in the Myozyme-treatedinfants compared with the known high mortality ofuntreated patients of similar age and disease severity. Thedrug's safety and effectiveness in other forms of Pompedisease have not been adequately studied.

A boxed warning is included in the Myozyme labelto warn about the possibility of life-threatening allergicreactions. Myozyme is manufactured by Cambridge,Mass.-based Genzyme Corp.

FDA Consumer / July-August 2005 / 3

Updates

Imaging System HelpsDetect Precancerous Cerv icalA b n o r m a l i t i e s

The FDA has approved an imagingsystem that can help detect an indication of the possible development ofc e r v i c a l c a n c e r.

The LUMA Cervical Imaging System,made by MediSpectra Inc., Lexington,Mass., can help identify sites on thecervix that may contain precancerouscells. It is intended to be used alongvirith colposcopy, a high-magnificationevaluation of the cervix, for women who

have recently had an abnormal Pap test.The firm's study of the device showedthat i t can detect addi t ional cancerprecursors missed by colposcopy.

"Cervical cancer is one of the fewhighly preventable cancers," says DanielSchultz, M.D., director of the FDA'sCenter for Devices and RadiologicalHealth. "The early detection andremoval of pre-cancerous cervicallesions reduces the risk of developingi n v a s i v e c e r v i c a l c a n c e r. "

The LUMA system shines a light onthe cervix and analyzes how different

areas respond to this light. The systemthen assigns a number, or score, totiny areas of the cervix, and produces acolor map that helps the doctor decidewhere to take a sample tissue, called abiopsy. The colors and patterns on themap help distinguish between healthyand potentially diseased tissue.

The FDA cautions that use of theL U M A d e v i c e i s n o t a s u b s t i t u t e f o ra thorough colposcopic exam, whichshould be performed first to identify areas on the cervix to perform abiopsy.

Another Option for Flu PreventionIn March 2006, the FDA approved the use of Relenza

(zanamivir, for inhalation) for the prevention of influenza in adults and children ages 5 years and older.Relenza, an antiviral medication, was previouslyapproved for the treatment of influenza A and B viralinfections in adults and children.

The approval of Relenza for prevention givesAmericans another option for preventing influenza Aand B infections. Tamiflu (oseltamivir phosphate) waspreviously approved for both prevention and treatmento f fl u .

The effectiveness of Relenza in preventing seasonalinfluenza has been demonstrated in four large-scalestudies comparing the drug with a pill containingan inactive ingredient (placebo). In two ofthese trials, the drug substantially reducedthe spread of influenza in the participatinghouseholds in which participants were 5years or older.

In the other two trials, conducted incommunities experiencing a flu outbreak,Relenza reduced the incidence of the disease in both young and older populations.In the first study, with participants ages18 years and older, the proportion ofpeople who developed symptomsconfirmed to be flu was 6.1 percentfor the placebo group and 2.0percent for the Relenza group.The second community studyenrolled people ages 12 to 94,with just over half older than 65.In this trial, the percentage ofpeople who developed symp

toms confirmed to be flu was 1.4 percent of the participants who took the placebo and 0.2 percent of thosewho used Relenza.

Breathing problems (bronchospasm), includingdeaths, were reported in some patients after the initialapproval of Relenza. Most of these patients had asthmaor chronic obstructive pulmonary disease. Because ofthese reports, Relenza is not recommended for treatmentor prevention of seasonal influenza in individuals withthese or other underlying airway diseases.

Relenza has not been proven effective for flu treatment in people with underlying airway disease, or forflu prevention in nursing homes. The drug also is not a

substitute for the flu vaccine, which is the primaryway to prevent the flu. Consumers should continue

receiving an annual flu vaccinationaccording to guidelines on immunization practices.

In preparation for a potential pandemic, the FDA has assembled thePandemic Influenza PreparednessTask Force to provide policy leadership and strategic planning on pandemic influenza.

The FDA also is working with thepharmaceutical industry to make

available appropriate products and toensure that mechanisms are in place to

collect the necessary efficacy and safetyinformation. Both Relenza and Tamifluhave been identified for stockpiling.

Relenza is manufactured and distributed by GlaxoSmithKline Inc., based inResearch Triangle Park, N.C.

4 / FDA Consumer / July-August 2006

Updates

Health Claim for Barley ProductsFood processors and manufacturers who market foods that contain a

specified amount of barley may include a health claim that their productsreduce the risk of coronary heart disease, under a new FDA rule. Specifically, whole grain barley and dry milled barley products such as flakes,grits, flour, and pearled barley, which provide at least 0.75 gram of solublefiber per serving, may bear the following claim:

"Soluble fiber from foods such as

[name of food[, as part of a diet lowin saturated fat and cholesterol, mayr e d u c e t h e r i s k o f h e a r t d i s e a s e . A

serving of [name of food[ supplies[x[ grams of the soluble fiber necessary per day to have this effect."

Coronary heart disease claims thelives of nearly 500,000 Americanseach year. High total cholesterollevels and high levels of low density lipoprotein (LDL) cholesterolare known to increase one's riskfor heart disease, so consumers areencouraged to keep these levels aslow as possible. Scientific evidenceindicates that including barley in a healthy diet can help reduce the riskof coronary heart disease by lowering LDL and total cholesterol levels.

"FDA is pursuing new initiatives to help consumers improve the choicesthey have for healthy and nutritious diets," says FDA Deputy Commissioner Scott Gottlieb, M.D. "We firmly believe that one of the best waysto encourage healthier eating habits is to help consumers get truthful,up-to-date, science-based information about food products so that theycan make choices that are based on a better understanding of the healthconsequences of their diets."

Generic Pravastatin ApprovedThe FDA has approved the first generic

version of Bristol-Myers Squibb's Prava-chol (pravastatin sodium) Tablets, animportant step in the agency's effort toincrease the availability of lower-costgeneric medications.

Pravastatin is indicated for the treatment of individuals who have highcholesterol levels (hyperlipidemia) orwho are at increased risk for atherosclerosis-related cardiac and cardiovascular events, such as heart attack andstroke in which high cholesterol levelsare a factor. In 2005, Pravachol was the22nd highest-selling brand-name drugin the United States, with sales totaling$1.3 bil l ion.

"This approval is another example ofour agency's endeavor to counter risinghealth care costs by approving safe andeffective generic alternatives as soon asthe law permits," says Scott Gottlieb,M.D., deputy commissioner for medical and scientific affairs. "Pravastatinis a widely-used cholesterol-loweringagent, and its generic version can bringsignificant savings to the millions ofAmericans with this disease."

Pravastatin Sodium Tablets (10 mg,20 mg, and 40 mg) are manufacturedbyTeva Pharmaceutical Industries Ltd.in Kfar Sava, Israel.

Agencies Create Model FoodEmergency Response Plan

The FDA, in cooperation with theNational Association of State Departments of Agriculture, the USDA's FoodSafety and Inspection Service, and theU.S. Department of Homeland Security, has announced the availabilityof a model Food Emergency ResponsePlan. The goal of the response plan is toenhance the protection of the nation'sagricultural industry and food security through prevention, detection,response, and recovery efforts.

The model plan provides states witha tool to use in developing their ownresponse plan for responding to a food-related emergency.

"FDA remains vigilant in its mission

to protect our country's food supplyand continues to maintain collaborative partnerships with our federal andstate partners by planning for, monitoring, and reacting to any potential threats," says Robert E. Brackett,Ph.D., director of the FDA's Center forFood Safety and Applied Nutrition."By collaborating more closely withour partners involved in food safetyand security, we will better leverageall of the available resources to be better prepared for any food emergencyi n c i d e n t . "

A food-related emergency involvesthe un in tent iona l or de l iberate con

tamination, threatened or actual, offood that may impact human health.

The model plan establishes a uniform structure and content that willresult in response plans similar amongall states. Plans developed in a similar manner will facilitate seamlessregional and national responses tofood emergencies.

The response plan was developedthrough a federal-state cooperativeagreement and in consultation with aconsort ium of stakeholders.

FDA Consumer / July-August 2006 / 5

Updates

New Treatment for Rare BoneM a r r o w C o n d i t i o n

The FDA has approved Dacogen(decitabine) injection for treating acondition in which a person's bonemarrow does not produce enoughm a t u r e b l o o d c e l l s .

People with myelodysplastic syndromes (MDS) have a lack of healthyblood cells that can function properly.Dacogen, manufactured by Pharm-achemie B.V. Haar lem, The Netherlands, is thought to work by promotingnormal development of blood cells.

The drug received orphan drug status for MDS because the cond i t ionaffects fewer than 200,000 people inthe Un i t ed S ta tes .

MDS can develop after treatmentwith drugs or radiation therapy forother diseases, or it can develop without any known cause. Some forms ofMDS can progress to acute myeloidleukemia, a type of cancer in which toomany white blood cells are made.

The FDA's approval of Dacogen"offers patients with this rare diseasean additional treatment option thatmay help these patients avoid bloodtransfusions," says Steven Galson,M.D., director of the FDA's Center for

Drug Evaluation and Research.T h e m o s t c o m m o n s i d e e f f e c t s

reported in clinical studies of Dacogenincluded low whi te b lood cel l count(neutropenia), low platelets in theblood (thrombocytopenia), anemia,fatigue, fever, nausea, cough, bleedingin the skin, constipation, diarrhea, andhigh blood sugar (hyperglycemia).

Remicade Approved for ChildrenW i t h C r o h n ' s D i s e a s e

The FDA has approved Remicade(infliximab) to treat children withactive Crohn's disease, a chronic,inflammatory condition of the bowelthat can be severely debilitating.Remicade was first approved in 1998to treat Crohn's disease in adults.

Remicade is a genetically engineeredmonoclonal antibody that is manufactured using cells containing human andmouse antibody genes. This biotechnology product, which is taken intravenously, blocks the action of a proteincalled tumor necrosis factor-alpha (TNF-alpha), one of the underlying causes ofinflammation in Crohn's disease.

The inflammation often involvesthe entire wall of the gastrointestinal tract and can result in abdominal

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pain, gastrointestinal bleeding, diarrhea or loose stools, blockages, andi n f e c t i o n s .

Steven Calson, M.D., director of theFDA's Center for Drug Evaluation andResearch, notes that there have beenno satisfactory treatments for childrenwith moderately to severely activeCrohn's disease who have symptomsdespite conventional therapies.

"Remicade is not a cure, but it provides a much-needed option for reducing the symptoms and inducing andmaintaining disease remission in children who have no other safe and effective therapy," says Calson. "We believethat the potential benefits of this product outweigh the risks that are knownand have been carefully evaluated."

The safety profile for Remicade in thechildren's study was similar to the datathat were presented at an FDA ArthritisAdvisory Committee meeting in March2003, and that dealt with the extent towhich anti-TNF therapies may increasethe risk of serious infections and illnesses, such as sepsis and pneumonia,in certain people.

These risks, which are described in astudy in the May 17, 2006, issue of theJournal of the American Medical Association, are included in the current labelsfor all approved TNF-alpha blocking agents, including Remicade. Morerecently, the FDA has received rarereports of an aggressive and often fataltype of cancer (hepatosplenic T-celllymphoma) in adolescents and youngadults with Crohn's disease who weretreated with Remicade. Most of thesepeople were receiving standard immunosuppressive therapies, such as aza-thioprine or 6-mercaptopurine, alongwith Remicade. The FDA is workingwith the manufacturer, Centocor Inc.of Malvern, Pa., to address this risk byupdating the "warnings" sections of theR e m i c a d e l a b e l .

The FDA continues to monitor thesafety of Remicade and similar treatments to maximize their benefits yetlimit, to the degree possible, the potential for very serious side effects.

6 / FDA Consumer / July-August 2006

Updates

MS Drug Back on Market Under Restricted Program

The FDA has approved an application to resume themarketing of Tysabri (natalizumab) under a specialrestricted distribution program. Tysabri is a drug usedto treat people with relapsing forms of multiple sclerosis(MS) to reduce the frequency of flare-ups.

Tysabri is approved for use as a monotherapy, meaningit should not be used with other drugs that modify theimmune system. Tysabri, which is injected directly intoa vein (infused), is for people who have not respondedto, or cannot tolerate, other treatments for MS.

The FDA initially approved Tysabri in November 2004,but the manufacturer Biogen Idee Inc. withdrew the drugin February 2005 after three patients in clinical trialsdeveloped a serious and rare viral infection of the brain.Two of the cases were fatal. On the basis of this information, the FDA put clinical trials of the drug on hold in February 2005. The FDA allowed a clinical trial of Tysabri toresume in February 2006 after reexamining the patientswho had participated in previous clinical trials and confirming that there were no additional cases of PML.

To decrease the possibility of people developing PML inthe future, while also making Tysabri available to thosewith MS who could benefit from it, the FDA consultedin March 2006 with its Peripheral and Central NervousSystem Drugs Advisory Committee. The committee recommended a risk-minimization program with mandatory patient registration and follow-up to identify as early

as possible any cases of PML that may occur and why. Inresponse, Biogen Idee submitted to the FDA a risk management plan, called the TOUCH Prescribing Program,to help ensure safe use of the product.

After a thorough review of the information providedby Biogen Idee, the FDA determined that Tysabri can bemade available under the TOUCH Program. Biogen Ideeand its distributor for Tysabri, Elan Pharmaceuticals Inc.,will manage the program, which includes the followingm a i n f e a t u r e s :• The drug will be prescribed, distributed, and infused

only by prescribers, infusion centers, and pharmaciesregistered with the program.

• Tysabri will be administered only to patients who areenrolled in the program.

• P r i o r t o t h e s t a r t o f t r e a t m e n t w i t h

Tysabri, health care professionalsare to obtain the patient's MagneticResonance Imaging (MRI) scan tohelp differentiate potential future MSsymptoms from PML.

• Patients on Tysabri are to be evaluatedat three and six months after the firstinfusion and every six months afterthat, and their status will be reportedregularly to Biogen Idee.

TysabrI(notdiuiimai:

300 mg/t5 mL(20nig/niLlIntravenous

entrcte forD \| "loctured by:

New Drug Treatment forP a r k i n s o n ' s D i s e a s e

The FDA has approved Azilect (rasa-gillne), a new drug for the treatmentof Parkinson's disease. Azi lect is amonoamine oxidase type B (MAO-B)inhibitor that blocks the breakdown ofdopamine, a chemical that sends information to the parts of the brain thatcontrol movement and coordinat ion.

"This is a welcome development forthe more than 50,000 Americans whoare each year diagnosed with Parkinson's disease," says Steven Galson,M.D., director of the FDA's Center forDrug Evaluation and Research. "Parkinson's is a relentless disease with limited treatment options, and each newtherapy is an important addition to thephysicians' treatment options."

Parkinson's disease is a chronic, pro

gressive neurodegenerative conditioncaused by the destruction of the braincells that produce dopamine. As thel e v e l o f t h i s c h e m i c a l d e c l i n e s , m e s

sages from the brain telling the bodyhow and when to move are deliveredmore slowly, leaving a person incapable of initiating and controlling movements in a normal way.

Azilect was approved for use as aninitial single drug therapy in earlyParkinson's disease, and as an additionto a s tandard Park inson 's d isease t reat

ment, levodopa, in people with morea d v a n c e d d i s e a s e .

People who take Azilect may have asudden, large increase in blood pressure (hypertensive crisis) if they alsoconsume tyramine-rich foods or beverages (such as cheese and red wine)or dietary supplements or amines con

tained in many cough and cold medications. A hypertensive crisis can leadto a stroke and death. People takingAzilect wil l need to avoid sources of

tyramines and amines. Like most othermed ica t ions fo r Park inson 's , Az i lec thas the potential to cause involuntarymovements , ha l luc inat ions, and lowered blood pressure.

During Azilect's development,melanoma was diagnosed in a smallnumber of people treated with the drug.The manufacturer, Teva PharmaceuticalIndustries Ltd., Israel, will performan after-market study to determinewhether or not Azi lect increases therisk of this form of skin cancer. Theproduct labeling will recommend thatpeople who take Azilect get periodicdermatologic examinations. ■

FDA Consumer / July-August 2006 / 7

Getting Ready forAnother Flu SeasonBy Linda Bren

Most people probably aren't thinking about flu season in the middle ofsummer. But government agencies are—in fact, they work year-roundto prepare for each influenza season and ensure that enough vaccine is

available to protect the American public.

An advisory committee to the Foodand Drug Administration has selectedt h e s t r a i n s o f i n fl u e n z a v i r u s t h a t w i l l

be included in this year's vaccine, andmanufacturers are already in production. And an advisory committee tot h e C e n t e r s f o r D i s e a s e C o n t r o l a n dPrevention (CDC) has recommendedwho should get flu vaccine during theupcoming flu season.

Influenza is a contagious respiratoryillness caused by the influenza virus.Flu season in the United States canbegin as early as October and can lastas late as May, according to the CDC.The season most often peaks in February or later. The past flu season startedoff with low levels of activity in October and November 2005, with activitypicking up considerably in December.The season peaked in early March 2006and continued at low levels into May.

The CDC reports that each year, 5percent to 20 percent of the 300 millionpeople in the United States get the flu.Most people recover in a week or twowithout complications. But more than200,000 are hospitalized with flu com

plications, and about 36,000 Americans die each year from the flu.

"Vaccination is still the best protection against influenza and can prevent many illnesses and deaths," sayslesse Goodman, M.D., director of theFDA's Center for Biologies Evaluationand Research. "Ensuring an adequate,safe, and effective supply of influenzavaccine each year is one of the FDA'shighest priorities."

Selecting the StrainsNew flu vaccine is made each year.

"Because the virus mutates, each year'svaccine may be different from the preceding year's," says Goodman. Thev a c c i n e i s a b l e n d o f t h r e e d i f f e r e n tinfluenza virus strains, and the formulation depends on the virus strainsthat are predicted to be circulating thatparticular flu season.

It takes at least six months to producea flu vaccine, so early in the year, theFDA's Vaccines and Related BiologicalProducts Advisory Committee meetsto decide which three strains of thev i r u s s h o u l d b e u s e d . T h e f o r m u l a

t ion se lec ted fo r the 2006-2007 seasonincludes one virus from last year's vacc i n e a n d t w o n e w v i r u s e s .

T h e F D A h a s l i c e n s e d f o u r m a n ufacturers to make flu vaccine for the2 0 0 6 - 2 0 0 7 s e a s o n . T h e v a c c i n e m a nufacturers estimate that between 100million and 120 million doses will beproduced, at least a 16 percent increaseover last season's 86 million doses. Theincreased production will help accommodate expanding vaccination recommendations as well as reduce the riskof shortages.

V a c c i n a t i o n R e c o m m e n d a t i o n s

Each spring, the CDC's AdvisoryC o m m i t t e e o n I m m u n i z a t i o n P r a ctices (ACIP) recommends who shouldget influenza vaccines in the upcoming flu season. After considering theACIP guidance, the CDC issues itsrecommendations during the summer. According to the CDC, peoplewho should get vaccinated each yearinclude those who are at high risk forcomplications from the flu, those whoare in contact with these high-risk indi-

The formulation selected for the 2006-2007 season includesone virus from last year's vaccine and two new viruses.

8 / FDA Consumer / July-August 2006

Centers for Disease Control and Prevention

Taronna Maines, Ph.D., a microbiologist in the Influenza Branch at the Centers for Disease Control and Prevention, conductsan experiment inside a biological safety cabinet (BSC) within the Biosafety Level 3-enhanced laboratory.

viduals, and people ages 50 to 64. Theupcoming season's high-risk categoryincludes children ages 6 months to 59months. The ACIP has recommendedvaccinating children in this age groupas well as their household contacts. Therecommendation expands last season'srecommendation to vaccinate childrenfrom ages 6 months to 23 months. Theexpanded age range means that anadd i t i ona l 5 .3 m i l l i on ch i l d ren and1 1 . 4 m i l l i o n h o u s e h o l d c o n t a c t s o r

caregivers should be vaccinated.The ACIP also emphasizes the impor

tance of giving two doses of influenza

vaccine, at least one month apart, tochildren between the ages of 6 monthsand 9 years who have never receivedi n fl u e n z a v a c c i n e .

Although anyone can come downwith the flu, infection rates are highest in children, according to the CDC.Children can spread the virus for twiceas long as adults and usually shedmore influenza virus, making themflu carr iers and sources of infect ionf o r o t h e r s .

The youngest children are at thehighest risk of influenza-related illnessand death, says Henry Bernstein, D.O.,

who serves on the American Academyof Pediatrics' Committee on InfectiousDiseases. "Children under 6 months of

age are very likely to be hospitalized ifthey get influenza. They are too youngto be immunized, so it's important toimmunize all family members, daycareworkers, and other close contacts." ■

F o r M o r e I n f o r m a t i o n

www.fda.gov/oc/opacom/hottopics/flu.html

FDA Consumer / July-August 2006 / 9

P h o t o t a k e

LASIK is an operation that reshapes the cornea to correct refraction and reduce the need for corrective lenses such as glassesor contact lenses. A specially designed instrument is used to lift a corneal flap in LASIK surgery.

10 / FDA Consumer / July-August 2006

By Carol Rados

~ ye problems, in general, tend to get overlooked in a— crowd of broader health issues such as heart disease

_ and cancer. For this reason, the vision health carecommunity has been working hard in recent years toemphasize the importance of proper eye care.

The focus, primarily, has been on objects reflect. To see clearly, light strik-' increasing the number of people ing the eye must be bent or "refracted"

who receive regular vision checks, through the cornea—the clear window1 and addressing diseases, injuries and, at the front of the eye that provides; according to the National Eye Institute most of the focusing power. Light trav-

(NEI), the most frequent eye prob- els through the lens, where it is fine-lems in the United States—defects or tuned to focus properly on the nerverefractive errors—most often respon- layer that lines the back of the eye, thesible for impairing vision. As a result, retina, and is then sent to the brainvision goals have been added recently through the optic nerve. The retinato a set of national health objectives, acts like the film in a camera, and clearcalled Healthy People 2010, which are vision is achieved only if light from anaimed at preventing disease and pro- object is precisely focused on it. If not,moting health. the image you see is blurred. This prob-

"These objectives are important lem is called a refractive error,because they give vision a prominentplace on the public health agenda," says Refractive ErrorsRosemary Janiszewski, the Healthy Refractive errors usually occur inPeople 2010 coordinator for the NET otherwise healthy eyes, and are caused"It is an acknowledgment from our mostly by an imperfectly shaped eye-country's leading health officials that ball, cornea, or lens, according to thevision plays a significant role in the NET Nearsightedness (myopia) andnation's overall health." farsightedness (hyperopia) are the

most common refractive errors. PeopleHow We See w i t h myop ia see nea r ob jec t s c l ea r l y.

The "Snellen Eye Chart," a series of while distant ones are blurred. Peopleletters arranged in lines, is the standard with hyperopia experience just thefor measuring how well each eye sees, opposite—they see distant objectsPeople view the chart at a distance of clearly, while near ones are blurred.20 feet. One eye is covered while the Uneven focus or distorted vision (astig-other is tested. matism) and aging eye that can't focus

Having 20/20 vision means seeing close up (presbyopia) are other com-at 20 feet what a person with normal mon refractive errors,vision sees at 20 feet. Someone able to The magnitude of refractive errorread additional lines smaller than the is measured in units called diopters,line representing normal vision has Each diopter of refractive error affects20/15, or even 20/10, vision. A person a person's ability to read smaller lineswho has worse-than-normal vision of an eye chart.and can only read letters larger than Why refractive errors develop is notthe 20/20 line has 20/40 vision, or known. The NEI says that most infantshigher. As a result, a person who has have some degree of hyperopia, but20/40 vision can see at 20 feet what the that vision becomes more normal withperson with normal vision sees at 40 age, usually leveling off by age 6. How-feet. And so on. ever, some children remain farsighted.

The eye does not actually "see" or become so later in life. While someobjects. Instead, it sees the light that children may be nearsighted early in

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Snellen Eye Chart

life, most myopia occurs later duringadolescence. Refractive error can continue to change over a person's lifetime.According to the NEI, 60 percent ofAmericans have refractive errors thatneed correcting for sharper vision.

Glasses, contact lenses, and various eye surgeries and procedures areaimed at reducing refractive errors byfocusing light rays properly on the retina. The past 20 years have seen manyinnovations in vision correction methods, including implantable intraocularlenses and different types of lasers usedto reshape parts of the eye, which areregulated as medical devices by theFood and Drug Administration.

The FDA says that it's important tolearn as much as possible about thedifferences between the available corrective lenses, new and older surgeries,and any other vision correction procedures. It's also important to know whatfactors make some a good candidatefor certain procedures but a poor cand i d a t e f o r o t h e r s .

Malvina B. Eydelman, M.D., director of the FDA's Division of Ophthalmic and Ear, Nose and Throat Devices,adds that it's important to weigh thebenefits and risks of each vision correction option, and to have realisticexpectations.

FDA Consumer / July-August 2006 / 11

n e a r

Normal Vision, 20/20 or betterf a r

P o i n t o f f o c u s i s o n t h e r e t i n a

Nearsighted or Myopic Vision

.1Point of focus is in front of the retina

Farsighted or Hyperopic Vision

%Point of focus is behind the retina

Infographic: FDA/Michael Ermarth

vk?nn°iT!fh "' ?® 'f focusing light on the retina. The retina acts like the film in a camera, and clearoftr ° T ° i!®"* precisely focused on it. If not, the image you see is blurred. This problem ismost often the result of an imperfectly shaped eyeball, cornea, or lens.

mmioSn''"I" (myopia) affects more than 30.5 million Americans age 40 or older. Hyperopia is less common, affecting 12million older Americans. Overall, 60 percent of Americans have refractive errors that need correcting for better vision.Source: National Eye Institute

Corrective EyewearThe NEI estimates that more than

150 million Americans spend over$15 billion each year on correctiveeyewear to compensate for refractiveerrors. Discussing the latest alternatives to corrective eyewear with an eyecare practitioner will help ensure thatany risks are minimized.

All contact lenses are regulated bythe FDA as medical devices. By law,

people need a prescription to buythem, even for "piano" lenses, whichare worn solely to change the appearance of the eye.

In addition, because people havemany choices in how, where, and fromwhom to buy contact lenses, the Federal Trade Commission (FTC) enforcesthe Contact Lens and Eyeglass Rules,which help increase the ability to shoparound. In this way, the FTC works

to prevent fraudulent, deceptive, andunfair business practices regardingcon tac t l enses .

Contact lens quality continues toimprove. Advances in materials havemade several types of precision contactlenses available for more people. Whiledifferent types of plastics offer optionsfor replacement and wear schedules,contact lenses are divided into twomain groups: soft and rigid gas-per-

12 / FDA Consumer/July-August 2006

meable (RGP), also called hard contactlenses. From there, the lenses are broken down based on what they're madeof, how often they need replacing, andwhether they can be worn overnight.

RGP lenses give clearer, crisper visionfor some people, according to the NEI.They tend to be less expensive overthe life of the lens, but the initial costoften is higher. RGPs last for severalyears, while soft contacts, dependingon the type, are meant to be replacedafter short periods. In addition, RGPlenses can be marked to show whichlens is for which eye, and they're lesslikely to tear or rip, making them easierto handle. It may take several weeks,however, to get accustomed to wearing rigid lenses, compared with severaldays for soft lenses.

Daily-wear soft contacts contain from25 percent to 79 percent water, are easy

to adjust to, and are initially more comfortable than RGPs, due to their abilityto conform to the eye and absorb water.Soft lenses aren't as likely to pop out orcapture foreign material, such as dust,as hard lenses. There are a variety of softlens materials available for some peoplewith very sensitive eyes.

The development of hyper-oxygen-transmissible lens materials, for both

rigid and soft lenses, has created a newgeneration of extended-wear contactsthat are intended to decrease the incidence of, and the risks for, lens-related

eye infections. Silicone hydrogel contact lenses, which, according to theNEI, allow physiological levels of oxygen to reach the ocular surface, haveimproved the safety of extended- orc o n t i n u o u s - w e a r c o n t a c t s . E x t e n d e d -wear lenses are available for overnight,and extended-wear disposables are soft

lenses worn from one to six days andthen discarded.

In October 2002, the FDA approveda new type of soft contact lens, safeenough to wear continuously for up to30 nights. These lenses allow six timesmore oxygen to reach the eye than previously approved lenses. All extended-wear contact lenses, however, carry agreater risk of serious eye infectionsthan lenses that are removed beforethe wearer retires for the day.

The replacement schedule of contactlenses refers to the length they can safelybe worn. RGPs generally are replacedevery couple of years because they aremade of a durable material, although aprescription change would mean newl e n s e s . S o f t c o n t a c t s c o m e i n a w i d e r

variety of replacement schedules.Some special features of many con

tact lenses, both soft and hard, include

Types of Contact Lenses

Types of Lenses A d v a n t a g e s D i s a d v a n t a g e s

Rigid gas-permeable (RGP)Made of slightly flexible plastics that allow oxygen to pass through to the eyes.

Excellent vision; short adaptationperiod: comfortable to wear; correctsmost vision problems; easy to put onand to care for; durable with a relativelylong life; available in tints (for handlingpurposes) and bifocals.

Require consistent wear to maintainadaptation; can slip off center of eyemore easily than other types; debriscan easily get under the lenses; requireoffice visits for follow-up care.

Daily-wear softMade of soft, flexible plastics that allowoxygen to pass through to the eyes.

Very short adaptation period; morecomfortable and more difficult to dislodge than RGP lenses; available in tintsand bifocals; great for active lifestyles.

Do not correct all vision problems; visionmay not be as sharp as with RGP lenses;require regular office visits for follow-up care; lenses soil easily and must bereplaced.

E x t e n d e d - w e a rAvailable for overnight wear in soft orRGP lenses.

Can usually be worn up to seven dayswithout removal .

Do not correct all vision problems;require regular office visits for follow-up care; increase risk of complication;require regular monitoring andprofessional care.

Extended-wear disposableSoft and worn for an extended periodof time, from one to six days, and thendiscarded.

Require little or no cleaning; minimalrisk of eye infection if wearinginstructions are followed; available intints and bifocals; spare lenses available.

Vision may not be as sharp as withRGP lenses; do not correct all visionproblems; handling may be mored i f fi c u l t .

Planned replacementSoft, made for daily wear, and arereplaced on a planned schedule, mostoften either every two weeks, monthly,or quarterly.

Require simplified cleaning and disinfection; good for eye health; available inmost prescriptions.

Vision may not be as sharp as withRGP lenses; do not correct all visionproblems; handling may be mored i f ficu l t .

Source: American Optometric Association

FDA Consumer / July-August 2005 / 13

bifocals, colored contacts, piano lenses,torics for astigmatism, and UV-block-ing contacts.

The rule of thumb for contact lenswearers, says James Saviola, O.D., chiefof the FDA's Vitreoretinal and Extraocular Devices Branch, "is to practicegood hygiene and follow manufacturers' instructions for proper use, cleaning, and storage of the lenses." Reportany signs of infection to your doctor,he adds. People should not wear contact lenses longer than the time prescribed by their eye care practitioner.But whatever is prescribed, Saviolasays, be sure to ask for written instructions and follow them carefully. Patientpackage inserts usually accompanycontact lenses, and people who are notoffered this information by their doctors should ask for i t .

Saviola says that a doctor must be certified to fit Ortho-K lenses.

P i a n o L e n s e s — W e a r e r B e w a r eAlso known as zero-powered, deco

rative, or noncorrective lenses, pianolenses at one t ime were consideredcosmetic devices. Their purpose is totemporarily change, for example, abrown-eyed person's eye color to blue,or to make a person's eyes look "weird"by portraying Halloween themes orthe logos of a favorite sport team. Butbecause these lenses carry the sameinfection risks to the eye as correctivecontact lenses, in 2005, they becamemedical devices by law.

"FDA strongly believes that eye careproviders are needed to fit decorative lenses," Saviola says, because ofconcerns about the potential for eye

"1 have had numerous experienceswhere a patient who was new to myoffice had purchased lenses at anestablishment that was less than optimal," she says. Two girls, in particular,came in with flaring, red eyes, Higginsrecalls. They were diagnosed with corneal ulcers as the result of overwearingcolored, nonprescription contact lensespurchased from a Dollar Store. Bothwomen had worn two-week, disposable lenses for over four months.

"1 am not against patients being ableto purchase lenses in places other thanmy office," Higgins says, "but 1 wantmy patients to be safe." Fortunately,she adds, since the new law requiring all contact lenses be dispensedby prescription only, "I've found thatpatients do realize the importance ofbeing fitted by a professional." Piano

'The FDA has never cleared an over-the-counter novelty lens.'

The most serious safety concernswith any contact lens deal with overnight use, or extended wear. Rigid orsoft, wearing these types of contactlenses overnight increases the risk ofcorneal ulcers—infection of the cornea that can lead to blindness. Symptoms include vision changes, eye redness, eye discomfort, and excessivetearing. Saviola advises that keepinglenses clean, replacing them often, andwearing them as prescribed by yourdoctor minimize the risks of wearingc o n t a c t s .

Orthokeratology (Ortho-K) is a nonsurgical procedure that uses RGP contact lenses to change the curvature ofthe cornea to improve its ability torefract light and successfully focus onobjects.

The Ortho-K system was initiallyapproved for daily wear. But in 2002,the FDA approved the lenses for overnight use. A person takes them out inthe morning to enjoy the day free ofcontacts. This method, however, doesnot produce a permanent result, and

problems, such as pink eye (conjunctivitis) and corneal ulcers. He says thatthe agency also informed health careprofessionals of the risk of blindnessand other eye injuries "if non-corrective, decorative, or cosmetic lenses aredistributed without an eye care professional 's involvement."

The FDA further advises people tonever buy such decorative lenses atany store that doesn't ask for a validprescription from an eye care professional. "The FDA has never cleared anover-the-counter novelty lens," saysSaviola. Such sales are illegal in theUnited States, and for good reason:wearing contact lenses that don't fitproperly is dangerous and can causeserious vision problems, abrasions,and infect ions.

Maria Higgins, O.D., F.A.A.O., anoptometrist who practices in Pittsburgh, was part of the National ContactLens Enforcement Petition in 2003 that

strongly encouraged the FDA to amendthe medical device laws to include regulation of all contact lenses.

lenses are as safe as any other contactlenses, Higgins adds, as long as peoplefollow the same rules for correctivec o n t a c t l e n s e s .

Corrective SurgeriesRefractive surgery includes several

surgical procedures designed to helpreduce the need for glasses or contactlenses. These procedures correct refractive errors by changing the focus ofthe eye. Common procedures such asphotorefractive keratectomy (PRK) andlaser in situ keratomileusis (LASIK) dothis by reshaping the curve of the cornea to move the point at which light isfocused onto the retina.

Various procedures with di fferent capabilities are available. Thereare now four categories of refractivesurgery procedures: excimer laser,implant, thermal, and other refractiveprocedures.

In PRK, an excimer laser capable ofremoving precise amounts of tissuewith micron accuracy is used to reshapethe central cornea—to flatten it to cor-

14 / FDA Consumer / July-August 2006

rect myopia, or to steepen it to correcthyperopia. PRK can also be used tocorrect astigmatism. The layer of cellscovering the cornea, the epithelium,is removed, and the laser sculpts thecornea to correct the refractive error.A bandage contact lens is placed overthe eye after the procedure to speed theepithelial healing process.

PRK gained popularity in the mid-1990s, but also was met with limitations. It worked best in patients withlow-to-moderate myopia, because withhigher levels, there was a risk of cornealhaze. The procedure also was associated with some physical discomfortafter surgery, since the cornea neededseveral days to heal. In some cases, itcould take severa l months to reach thebest level of v is ion.

By far the most popular vision correction procedure has been LASIK.Surgeons use a surgical knife, called amicrokeratome, to create a hinged flapon the surface, fold it over to sculpt theunderlying cornea into a new shape,and fo ld i t back on to the cornea.

To encourage her daughter to consider LASIK, Becky Ricketts, 51, of Mt.Airy, Md., underwent the procedure forsevere astigmatism in both of her eyestwo years ago.

"1 decided to be the guinea pig," shesays. "My daughter's eyes were so bad,1 just believed she would be better offhaving LASIK, based on results of thepeople I knew who'd had it done."

Ricketts's eyesight, though not aspoor as her daughter's, was such thatshe wore glasses every day for most ofher life, but not so bad that she waslegally required to wear them to drive."I've always passed my driving testswithout glasses," she says. She doesadmit, however, that she squintedin front of the computer screen, andclaims that without glasses, "everything had a fuzzy look." She was notable to wear contact lenses becausethe astigmatisms were so severe that"if I blinked, the contacts moved andI couldn't see." In fact, any movementof the head, Ricketts says, caused hercontact lenses to move.

The advantages of LASIK include aquicker visual rehabilitation, reducedpain and discomfort, and the surgeon'sability to treat higher levels of refractive

er ro r w i t hou t t he l im ita t ions associated wi thP R K .

T h r e e y e a r s a f t e rLASIK, Ricketts says, "Myv is ion cou ldn ' t be be tter. I'm happy I had thesurgery," she says, "but1 didn't spend my lifewanting to have it done."Although she still wearsglasses to correct presbyopia, Ricketts is currently considering a relatively new procedure thatw o u l d r e d u c e h e r n e e dfor reading glasses.

Doctors say that oneof the keys to a successful LASIK procedure ist h e m e a s u r e m e n t t h a t a n

ophthalmologist takest o d e t e r m i n e r e f r a c t i v eerror. Small imperfections in the eye maycause some light to travelthrough the eye at different angles, making lightstrike the retina in different places. Collectively,these imperfections arecalled optical aberrat i o n s .

Tradit ional laser technology allows for cor-rection of the refractiveerrors myopia, hyperopia, and astigmatism, also known as "lower order"aberrations. A new excimer laser procedure called wavefront-guided LASIKtreats lower order and "higher order"aberrations, which are subtle focusingimperfections in an eye's optical system that can result in less-than-opti-mal clarity.

Wavefront, or custom LASIK, uses ameasuring device to create a "map" ofhow a person's eye focuses light to precisely assess the unique irregularitiesand variations of the eye. These variations, experts claim, can be as uniqueas a person's fingerprints.

The FDA approved the excimer laserfor use in wavefront-guided LASIK in2003. Ricketts's 28-year-old daughter,Lindsey Hocker, of Frederick, Md.,underwent the relatively new customcorneal surgery less than one year after

B l a c k S t a r / D e n n i s B r a c k

To encourage her daughter to consider LASIK,Becky Ricketts, 51, of Mt. Airy, Md., underwent theprocedure for severe astigmatism in both of her eyes.Ricketts's 28-year-old daughter, Lindsey Hocker, ofFrederick, Md., underwent wavefront-guided LASIKi n 2 0 0 5 .

it first became available."Regular LASIK came highly recom

mended to me by several people, andseeing the success that Mom had withLASIK convinced me to do it," Hocker

says. "But because of the problems Ihad, I decided to go with my doctor'srecommendat ion for the custom corn e a . "

The wavefront map is very detailed:Instead of simply creating a generaldescription of the eye's focusing power,for example, nearsightedness, farsightedness, or astigmatism, it records everysubtle distortion in the pathway oflight moving through the eye.

"Immediately after the surgery,"blocker says, "I could see the clockon the wall for the first time since thefourth grade." The only side effect shehas experienced in two years was dryeyes after surgery.

FDA Consumer / July-August 2005 / 15

Vitreous gel

Optic nerveC o r n e a

M a c u l a

R e t i n a

Diagram of the Eye National Eye Institute

Although it's natural for people towant to hear the success stories of others who have undergone a type of surgery, the FDA recommends that people avoid being influenced by othersencouraging them to have such procedures. Not everyone is a candidate forevery procedure.

Laser Epithelial Keratomileusis, orLASEK, is a variation of LASIK, andcorrects myopia, hyperopia, and astigmatism. The epithelium, or outer surface of the cornea, is loosened withalcohol, not with the microkeratomeused in LASIK. It is then peeled back toexpose the cornea. The same excimerlaser used in LASIK is applied to thecornea, but only to the surface. Theepithelium is placed back into position,and a bandage contact lens is placed onthe eye to promote healing. Like LASIK,the recovery time is rapid. Discomfortis somewhat increased, compared withL A S I K .

LASEK is similar to PRK. The difference is that with LASEK, the epithelium is replaced after surgery. In PRK,the epithelium is discarded. Both PRKand LASEK are similar to LASIK in thatthey use the excimer laser to shape thec o r n e a .

While the FDA regulates excimer

lasers, the agency doesn't have theauthority to regulate a doctor's practice of medicine or the off-label use ofmedical products. Therefore, the FDAdoes not tell doctors what to do when

running their businesses or what theycan or cannot tell their patients. Consequently, people considering lasersurgery should ask questions and fullyunderstand any procedure they mightbe considering.

The idea of a person walking into adoctor's office and an hour later walking out with perfect vision is a veryattractive one, but the reality is thatthese are surgical procedures withpotential complications, and perfectresults are not guaranteed, expertssay. Everette Beers, Ph.D., chief of theFDA's Diagnostic and Surgical DevicesBranch, reminds people that refractivesurgeries are elective procedures, someof which can't be undone.

"People need to remember that youcan change glasses or contacts, but notimplants or surgery," he says. Be sureto consult with a refractive surgeon todetermine your eligibility for surgery.Beers also warns that surgical procedures are not without some risk, andthat "the long-term effects of manyprocedures are still unknown."

According to the American Academyof Ophthalmology (AAO), more than90 percent of people who have refractive surgery for myopia and astigmatism end up with 20/40 vision or betterwithout glasses, a correction sufficientenough to allow them to drive legallywithout glasses. Sixty percent to 70 percent of patients achieve 20/20 visiono r b e t t e r.

Implant ProceduresCorrective artificial lens implants

give people who don't want to botherwith eyeglasses or manual insertionof contact lenses another option toc o n s i d e r .

Intrastromal corneal ring segmentsare semicircular pieces of plastic thatare implanted within the cornea totreat mild forms of myopia. They alsoare sometimes used for other conditions affecting the cornea. The insertsare designed to change the shape of thecornea by adjusting the focusing powerof the eyes so that light is focused ontothe ret ina. A small incision is madenear the upper edge of the cornea, inwhich the ring segments are inserted.The incision is closed with two smallsutures that are usually removed twoto four weeks after surgery.

While tissue removed during lasereye surgeries cannot be replaced, theintrastromal corneal ring segments arer e m o v a b l e .

Phakic Intraocular Lenses (phakiclOLs) are new devices made of plastic or silicone, approved by the FDAfor correcting nearsightedness. Thesethin lenses are implanted into the eyeto help reduce the need for glasses orcontact lenses. A small incision is madein the front of the eye, in which thephakic lens is inserted. Phakic refersto the lens being implanted into theeye without removing the eye's naturallens. Since phakic lOLs involve entering the eye, unlike LASIK and PRK, therisk of complications is higher.

Phakic lenses are intended to be permanent. If a cataract develops, however, the natural and phakic lenseswould be removed and replaced withartificial lenses, says Kesia Alexander,Ph.D., chief of the FDA's Intraocularand Corneal Implants Branch. But, sheadds, "there's no guarantee that the

16 / FDA Consumer / July-August 2006

eye will return to its previous level ofvision." Alexander also says that whilephakic lenses are a good alternative forpeople who are very myopic and can'tbe corrected with LASIK, "there's noguarantee that you won't always be ableto go without glasses."

T h e r m a l P r o c e d u r e sConductive keratoplasty (CK) uses

radio frequency energy, instead of alaser, to bend the cornea. Also knownas "blended vision," CK corrects forhyperopia. By overcorrecting the cornea, CK causes the eye to becomenearsighted. "CK achieves its correction of presbyopia," says Beers, "byinducing monovision with one nearsighted eye."

CK does not involve making an incision, but instead, a tiny probe releasescontrolled amounts of very low heatfrom radio frequency energy, causingthe outside area of the cornea to tightenlike a belt, making the central corneasteeper. CK causes little or no discomfort or irritation, and vision improvement is almost instantaneous. Unlikeother types of refractive surgery, suchas LASIK, however, correction from CKmay be temporary and re-treatmentmay be necessary.

Other Refractive SurgeryP r o c e d u r e s

Accommodative and multifocal lOLsare used to treat nearsightedness, farsightedness, and the inability to focusup close because of age. These artificiallenses are surgically implanted in theeye. Unlike the phakic lOLs, which areimplanted in front of the eye's naturallens, accommodative and multifocallOLs actually replace the eye's natural lens once a cataract has developed.These lenses enable the eye to regain itsfocusing and refractive ability.

Monovision is a corrective techniqueused to treat people with presbyopia.The intent is for the person to use oneeye for distance viewing and one eyefor near viewing. Having each eye configured for different focusing distancescan reduce or eliminate the need foreyeglasses or contact lenses.

The practice was first applied to contact lenses, and more recently to LASIKand other surgeries. In refractive sur-

Who Does What?Eye care professionals have different educations, and the services they canprovide, described below, are determined by varying regulations:• Opticians grind and dispense eyeglasses, and in some states, fit

contact lenses, following prescriptions written by optometrists orophthalmologists.

• Optometrists (O.D.) examine eyes, diagnose and treat vision problemsand abnormalities, and prescribe eyeglasses and contact lenses. Themedications they are licensed to prescribe to treat eye conditions varyby state.

• Ophthalmologists (M.D. or D.O.) are physicians who specialize intreating eye diseases. They are trained to perform eye surgery. ■

gery, the technique treats one eye tofocus at close proximity, while theother eye is left untreated or, if needed,treated to be able to focus at a distance. This method may be difficult toadjust to at first but, according to theInternational Society of Refractive Surgery, about six to eight weeks after themonovision procedure, most people'sbrains are able to adjust to the differentfocusing ability of the eyes.

The FDA recommends that anyoneconsidering monovision try the contact lens procedure first, as a trial run,before having the surgery, which is permanent. Also, it's important to checkstate drivers' license requirements withm o n o v i s i o n .

Eyeglasses—^The Reliable StandbyIn some cases, modern technology

can provide the best vision correction option. In those cases in whichit can't, eyeglasses may be the way togo. Glasses correct refractive errors byadding or subtracting focusing powerto the cornea and lens. The powerneeded to focus images directly on theretina is measured in diopters. Thismeasurement is also your eyeglassprescription.

Like contact lenses, glasses come inall shapes and sizes, offering an arrayof choices for both function and fashion. Eyeglass frames, for example, aremore durable and tout materials suchas titanium and new "memory metals." Manufacturers are making lensesthat are thinner, stronger, and lighter.And lens options include antireflective

coating, light-changing tints, line-free(progressive) bifocal, and polycarbonate—the most impact-resistant lensm a t e r i a l a v a i l a b l e .

Regular eye exams are importantbecause they can detect early signs ofdisease and refractive error long beforeeither leads to vision impairment. Doctors recommend that everyone havean eye exam shortly after birth, andat least every few years until age 40.After that, the eyes should be routinelychecked every two or three years. People with diseases such as diabetes andhypertension should have their eyeschecked more frequently. ■

F o r M o r e I n f o r m a t i o nFood and Drug Administrationwww.fda.gov I cdrhlcontactlensesiwww.fda.gov I cdrhjlasiklwww.fda.gov I cdrhlphakicj

National Eye Institutewww.nei.nih.gov

American Academy ofOphthalmologyw w w. a a o . o r g

American Optometric Associationw w w. a o a n e t . o r g

Federal Trade Commissionwww.ftc.gov

Association of Regulatory Boards ofO p t o m e t r ywww.arbo.org

DA Consumer / July-August 2006 / 17

S o m eM o v e

Cold MedicinesBeh ind Counte r

By Linda Bren

Some over-the-counter (OTC) cold and allergy medicines are being moved behindthe counter at pharmacies nationwide as part of the fight against illegal drugproduction.

Under the Patriot Act signed by President Bush on March 9, 2006, all drugproducts that contain the ingredientpseudoephedrine must be kept behindthe pharmacy counter and must besold in limited quantities to consumers after they show identification andsign a logbook.

Pseudoephedrine is a drug found inboth OTC and prescription productsused to relieve nasal or sinus congestion caused by the common cold, sinusitis, hay fever, and other respiratoryallergies. The drug is also a key ingredient in making methamphetamine—apowerful, highly addictive stimulantoften produced illegally by "methcooks" in home laboratories.

The new legal provisions for sellingand purchasing pseudoephedrine-con-taining products are part of the Combat Methamphetamine Epidemic Actof 2005, which was incorporated intothe Patriot Act. These "anti-meth" provisions introduce safeguards to makecertain ingredients used in methamphetamine manufacturing more difficult to obtain in bulk and easier forlaw enforcement to track.

According to the National Instituteon Drug Abuse, methamphetamine useand abuse is associated with serioushealth conditions including memoryloss, aggression, violence, paranoia,hallucinations, and potential heart andbrain damage. The Drug Enforcement

Administration says there is a directrelationship between methamphetamine abuse and increased incidents ofdomestic violence and child abuse.

Meth users ingest the substance byswallowing, inhaling, injecting, orsmoking it. There are currently no safeand tested medications for treatingmethamphetamine addiction.

The new law affects several hundred OTC products for children andadults, such as Sudafed Nasal Decongestant Tablets, Advil Allergy SinusCaplets, TheraFlu Daytime Severe ColdSoftCels, Tylenol Flu NightTime Gel-caps, and Children's Vicks NyQuilCold/Cough Relief. "There are veryfew decongestants on the market thatdon't contain pseudoephedrine," saysCharles Ganley, M.D., director of theFood and Drug Administration's Officeof Nonprescription Products.

Ganley says that products containing pseudoephedrine are still available without a prescription and thatthey are packaged the same way as anyOTC drug. "The only difference is thatpeople will have to go to the pharmacist to buy them," he says. "They justneed to ask for them and show ID, andknow that there's a limit to the amountthey can purchase."

Buyers must show a government-issued photo ID, such as a driver'slicense, and sign a logbook. Stores arerequired to keep a record about pur

chases, which includes the productname, quantity sold, name and addressof purchaser, and date and time of thesale, for at least two years. Single-dosepackages containing 60 milligrams orless of pseudoephedrine are excludedfrom the recordkeeping requirement,but must still be stored behind thec o u n t e r .

The federal law l imi ts the amountof pseudoephedrine an individual canpurchase to 3.6 grams in a single dayand 9 grams in a month at a retail store.For example, a person may buy AdvilAllergy Sinus Caplets, which containpseudoephedrine and other ingredients, in quantities of up to 146 tablets in one day and 366 tablets in onemonth. The number of pills or amountof liquid medicine allowable will varydepending on the type of product andits strength.

The limits on the amount an individual can purchase became effective April 8, 2006. The requirementsto place products behind the counterand to keep a logbook take effect Sept.30, 2006. Many drug stores are alreadycomplying voluntarily or because somestate laws require similar controls.

Drug companies are reformulatingsome of their products to eliminatepseudoephedrine. Pfizer, for example, while still offering Sudafed nasaldecongestants, which contain pseudoephedrine, also markets a line called

18 / FDA Consumer/July-August 2006

A s s o c i a t e d P r e s s

A warning display appearing on a cash register when more than three boxes of Sudafed are purchased is shown at aWal-Mart Store in Troy, Mich.

Sudafed PE as an "on the shelf" alternative. Sudafed PE contains the activeingredient phenylephrine, which is notused to make methamphetamine, andso is not under the same restrictions aspseudoephedrine.

"Drugs that contain phenylephrineare also safe and effective," says Gan-ley. "The dosing is a little different—you have to take them a little morefrequently than the pseudoephedrine-containing drugs because their effectsare not as long-lasting."

The anti-meth provisions of thePatr io t Act rest r ic t the sa le of twoother drug ingredients, ephedrineand phenylpropanolamine, becauseof their potential to be used illegally

to make methamphetamine. Like pseudoephedrine, drugs containing theseingredients must be placed behind thecounter, and buyers must show identification to purchase a limited quantity.

Synthetic ephedrine is used in sometopical drugs, such as nose drops, totemporarily relieve congestion dueto colds, hay fever, sinusitis, or otherupper respiratory allergies. It is alsoused orally for temporary relief ofasthma symptoms.

Phenylpropanolamine was commonly used in OTC decongestants andweight-loss drugs. Today, it is unlikelythat consumers will find phenylpropanolamine in their drug stores, saysGanley. In 2000, the FDA asked drug

manufacturers to discontinue marketing products containing phenylpropanolamine because of an increased riskof bleeding in the brain (hemorrhagicstroke) associated with the ingredient.The FDA has taken regulatory actionsto remove phenylpropanolamine fromall drug products. ■

F o r M o r e I n f o r m a t i o n

www.fda.gov I cderI news Imethamphetamine. htm

FDA Consumer / July-August 2006 / 19

Medicat ion Use

20 / FDA Consumer / July-August 2006

and Older AdultsBy Michelle Meadows

A brown paper bag may hold the key to safer use of medications, according to health experts.

"A 'brown bag checkup' is the single best thing that patients can do toavoid medication mistakes and cut down on unnecessary medications,"

says Douglas Paauw, M.D., professor of medicine at the University ofWashington in Seattle. "But I would estimate that only about 10 percentof people actually do it."

The checkup involves putting all of your medications and over-the-counter

products in a brown paper bag and bringing them into your doctor'soffice. The bag should include any over-the-counter or prescription drugs,herbs, vitamins, dietary supplements, and topical treatments such asointments and creams. "This kind of checkup is a good idea for anyone

who takes medication, but particularly for older people who are themost likely to be taking several medications," Paauw says. The average75-year-old has three chronic conditions and uses five prescription drugs,according to a report from the Merck Institute of Aging & Health.

John Lowery, 87, of Delphi, ind., goes through his daily medications with his physician, Lisa McTavish,M.D. Lowery carries his medication list in his wallet, keeps it on his computer at home, and givesa copy of it to his doctor every time he sees her.

Black Star/John Starkey

FDA Consumer / July-August 2005 / 21

Researchers at Pennsylvania StateUniversity found that when adultsages 65 to 91 were asked to bring inthe brown paper bag containing theirmedicines, the l ist of medications inthe bag was more complete than theirofficial pharmacy records. And peoplewith worse health consistently hadpoorer matches between the brownbags and the paperwork.

"If not a paper bag, then write outa list and bring that in," Paauw says.Y o u c o u l d a l s o s h a r e t h e i n f o r m ation with your pharmacist, who cancheck for drug duplications, interaction problems, inappropriate dosing,and whether each drug is being givenfor the right indication.

The idea is to have at least one health

care professional informed about everything that you take. "This should bedone at least every year and preferablymore often," Paauw says. "Some of mypatients do it at every visit."

W h e n t h e b o t t l e s a n d t u b e s a r e

spread out on the table, the picture

Living LongerLife expectancy in the United

States is at an all-time high.According to the latest data fromt h e C e n t e r s f o r D i s e a s e C o n t r o land Prevention, life expectancyfor the total population was 77.6years in 2003—74.8 years formen and 80.1 years for women.The fastest-growing segment ofthe population is the age group85 and o lde r. ■

lems include expired medications andmedications that are no longer needed,bu t we re neve r r eeva lua ted .

After you and your doctor settle onwhat you should be taking, then thenext thing is for you to know the nameof your medication and what it's for,says Karen Gunning, Pharm.D., associate professor of pharmacy practiceat the University of Utah in Salt Lake

that you have it," Gunning suggests."Patients should be able to take that l ist

out at the dentist's office, an appointment with a specialist, or in an emergency," she says. "But it's not uncommon for an older patient to come tothe hospital and say that their doctorgave them a white pill and that's allthey know."

John Lowery, 87, Delphi, Ind., carrieshis medication list in his wallet, keepsit on his computer at home, and gives acopy of it to his primary care doctor everytime he sees her. His oldest son, 65, livesnearby and also knows about the list.

Sticking With the PlanSetter, a pharmacist who helps older

people manage their lives at home,says he often discovers that patientsstray from their medication plan andtha t the i r doc to r i sn ' t aware o f i t . " I ' veseen a person's blood pressure go upbecause the patient hasn't been takingthe medication, but the doctor thinksthe drug isn't working," Setter says. "So

'When someone pulls out 10 bottles, then something mightnot be right and we can make adjustments.'

becomes clear. "When someone pulls City. "If an older person has memory a second medication is added or theout 10 bottles, then something might problems or difficulty with compre- dose is increased when the problem isnot be right and we can make adjust- hension, a family member or caregiver really a compliance issue." Setter saysments, Paauw says. The doctor can could help," Gunning says. that when this happens, he contactsalso see that your multivitamin with Setter cites an example in which the doctor and talks with the patientiron is the reason your thyroid treat- one of his older patients mistakenly to reinforce the importance of two-wayment isn't working. "Both iron and cal- thought her glaucoma medication was communication,cium supplements can interfere with for treating headaches. "Soshewastak- Robert Ferguson, M.D., chief ofthe absorption of thyroid medicine," ing her eye medication only when she internal medicine at Union Memo-says Paauw, who gave a talk on com- had a headache, but she should have rial Hospital in Baltimore, says thatmon drug errors at the annual meeting been taking it every day to treat her intentional noncompliance with theofthe American College of Physicians eye disease," Setter says. Experts say regimen typically occurs because thein April 2006. that it's important to understand your patient can't afford the medicine or

Stephen Setter, Pharm.D., associ- medications because you are more is worried about side effects. "Whenate professor of pharmacotherapy at likely to take the medicine correctly, noncompliance is unintentional," Fer-Washington State University in Spo- more likely to know what to expect guson says, "it's usually because com-kane, says doubling up on therapy is from the medication, and better able plying with the regimen became tooanother common problem. "Someone to report what you are taking to your difficult. It's so complex that it's toomay be taking two products containing doctors and pharmacist. hard to keep it up."acetaminophen, which raises the risk "Keep the list of medications in your Ferguson says he teaches medicalof liver damage. Other common prob- wallet and let a family member know residents that the regimen should be

22 / FDA Consumer / July-August 2006

Getty Images

A friend or a relative can accompany an older person to a doctor appointment to help ensure that instructions for medicinesa r e u n d e r s t o o d a n d r e m e m b e r e d .

as simple as possible and effective, ands h o u l d r e s u l t i n m i n i m a l s i d e e f f e c t s .

"Sometimes, we can reduce the numberof medications by treating two problems with one medication," Fergusonsays. There also are ways to make theschedule simpler such as switchingfrom a medicine that's given threetimes a day to another medicine thatcan be given once a day.

You can make sticking to a scheduleeasier by attaching the medications tomeals or other daily activities. Lowerysays this works for him. "The threemed ica t i ons t ha t I need t o t ake i n t he

morning go on top of the refrigeratorand I have them with breakfast," hesays. "I take the others at night beforeb e d t i m e . "

For more complicated regimens, pillboxes with compartments can help.Pill boxes are also useful for peoplewho have trouble opening pill bottles.Setter says, "You can ask for pre-filledpill boxes or request bottles without

child-proof caps if no children live ino r v i s i t t h e h o m e . " P h a r m a c i e s u s u

ally charge a nominal fee for pre-filledpill boxes.

Everything from gadgets that beepto simple medication charts posted onthe refrigerator can serve as reminders."For some people, we color code themedication bottles or use a big pictureof the sun to signal morning medications," Setter says.

Setter says he talks with many olderpeople who are confused about thepurpose of the drug and the instructions. "The typical scenario is that apatient has three new prescriptionsand had to wait in the pharmacy for30 minutes, so they just want to get theprescriptions filled and go," he says."Health providers need to speak moreslowly and take the time to explain,which can be a challenge," Setter says."And patients should ask questions.But people get intimidated and don'twant to ask or they feel like they don't

have time to ask questions." Writingquestions down is always a good idea.Setter says. "Family members and caregivers can help with this."

Examples of questions to ask about an e w m e d i c a t i o n : W h a t s h o u l d I d o i f I

forget a dose? Should 1 take the medicine before, during, or after meals?What should the timing be betweene a c h d o s e ?

With some diseases, people maystop taking medication because theydon't understand why they are takingit or don't feel that it helps. "But wedon't want people to stop taking anosteoporosis drug and then have afracture a year later," Setter says. "Andwith a diabetes drug, we are hoping toprevent blindness, amputation, andkidney disease."

Lowery, who has survived a heartattack and kidney failure, says he isdiligent about managing his medications because he feels they improve hisquality of life. From the pills that ease

FDA Consumer / July-August 2006 / 23

Most medication side effects are mild and maylessen over time. But if they are bothersome, you should

discuss them with your doctor.

his joint pain to the drops that soothehis dry eyes, medications help him stayactive. "1 keep up a garden and go tobluegrass music festivals," Lowery says.He also visits Helen, his wife of 66 years,every day at the nursing home.

Managing Side EffectsMost medica t ion s ide e f fec ts are mi ld

and may lessen over time. But if theyare bothersome, you should discussthem with your doctor. The doctor mayswitch to a different drug or change thedose. "Neither patients nor physiciansshould shrug off side effects by chalking them up to old age," Setter says." A n d s i d e e f f e c t s s h o u l d n ' t b e t r e a t e d

with more drugs."Compared with younger people,

older people can be more likely toexperience some side effects, Ferguson says. Side effects may also be moretroublesome than they would be forsomeone younger. There are no absolutes here. Some robust 85-year-oldsc a n h a n d l e a m e d i c a t i o n b e t t e r t h a na 50-year-old who has a lot of healthproblems. But generally, older peoplehave a decline in liver and kidney function, which affects the way a drug isb r o k e n d o w n a n d r e m o v e d f r o m t h e

body. "The kidneys decline about 1percent each year starting at age 40,"Ferguson says. "Medication stays in the

body longer and side effects can havebigger consequences in older people."

Examples of side effects that mayaffect older people more than youngerpeople are dizziness, dry mouth,drowsiness, falls, depression, insomnia, nausea, and diarrhea. David Greeley, M.D., a neurologist at NorthwestNeurological Institute in Spokane, saysthe effects of sedating antihistaminessuch as diphenhydramine can be disastrous in older people.

D iphenhydramine is commonlyfound in over-the-counter sleep aidssuch as Unisom Sleep Gels, Tylenol PM,and cold and allergy medicines suchas Benadryl. Greeley says, "Whereas

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At about age 40, kidney function begins to decline.As a result, medications remain in the body longer,which can have serious consequences.

24 / FDA Consumer / July-August 2006

Tips for Seniors on Safe Medicine Use1. Learn about your medicines. Read medicine labels and package inserts and follow the directions. If you

have questions, ask your doctor or other health care professionals.

2. Talk to your team of health care professionals about your medical conditions, health concerns, and allthe medicines you take (prescription and OTC medicines), as well as dietary supplements, vitamins, andherbals. The more they know, the more they can help. Don't be afraid to ask questions.

3. Keep track of side effects or possible drug interactions and let your doctor know right away about anyunexpected symptoms or changes in the way you feel.

4. Make sure to go to all doctor appointments and to any appointments for monitoring tests done by yourdoctor or at a laboratory.

5. Use a calendar, pill box, or other things to help you remember what you need to take and when. Writedown information your doctor gives you about your medicines or your health condition.

6. Take along a friend or relative to your doctor's appointments if you think you might need help tounderstand or to remember what the doctor tells you.

7. Have a "Medicine Check-Up" at least once a year. Go through your medicine cabinet to get rid of oldor expired medicines and also ask your doctor or pharmacist to go over all the medicines you now take.Don't forget to tell them about all the OTC medicines or any vitamins, dietary supplements, and herbalsyou take.

8. Keep all medicines out of the sight and reach of children.

Source: FDA/Centerfor Drug Evaluation and Research

a younger person can take it at nightand feel back to normal by morning,the medication can linger in the systemof someone older, which may result inf a l l s a n d c o n f u s i o n . "

Paauw says diphenhydramine canalso affect a man's prostate gland. "Anolder person who already has troubleurinating can end up in the emergencyroom with urinary retention," he says.

Another example is the drug Mira-pex (pramipexole), a treatment forParkinson's disease, for which there isa n i n c r e a s e d r i s k o f h a l l u c i n a t i o n s i n

people older than 65 compared withpeople younger than 65. "Quinoloneantibiotics may also cause hallucinations," Paauw says. Examples of quinolone antibiotics include Cipro (ciprofloxacin), Levaquin (levofloxacin),and Floxin (ofloxacin).

In 2005, the Food and Drug Administration warned the public about theuse of certain drugs called atypicalantipsychotic drugs. The drugs areapproved to treat schizophrenia and

m a n i a , b u t c l i n i c a l s t u d i e s o f t h edrugs to treat behavioral disorders inolder patients with dementia showeda higher death rate associated withtheir use when compared with patientsreceiving an inactive pill (placebo). The

Maturity HealthM a t t e r s

"Maturity Health Matters," anon l ine news le t te r fo r o lder adu l tsand their caregivers, is publishedthree times a year by the FDA'sCenter for Devices and Radiological Health. The inaugural issue,published in November 2005,f o c u s e d o n m e d i c a l d e v i c e s .F u t u r e i s s u e s w i l l i n c l u d e a r t icles on drugs, biologies, foodsafety, and other areas regulated by the FDA. Visit www.fda.gov/cdrh/maturityhealthmatters / tov iew the la tes t i ssue . ■

advisory applies to these antipsychoticdrugs: Abilify (aripiprazole), Risperdal (risperidone), Zyprexa (olanzapine), Geodon (ziprasidone), Seroquel(quetiapine), and Clozaril (clozapine).Symbyax (olanzapine and fluoxetine),which is approved to treat depressiveepisodes associated with bipolar disorders, was also part of the advisory. Thecauses of death in older patients werevaried, but most appeared to be relatedto the heart or pneumonia.

Reducing ErrorsSetter says that older adults sometimes

inadvertently receive an initial dose ofmedication that's too high. "The dosemay be totally appropriate for a youngeradult," Setter says, "but with the agingprocess, an older adult is less able to tolerate the typical starting dose."

Health care providers try to find abalance tbat gives older people appropriate medications and appropriatedoses. Experts say the philosophy hasalways been "start low and go slow"

FDA Consumer / July-August 2005 / 25

Testing Drugs in Older PeopleSince 1999, drug manufacturers have been required to analyze data on

older patients, says Robert Temple, M.D., director of the FDA's Office ofMedical Policy. Most drugs submitted to the agency have been examinedfor effects in people older than 65, and most prescription drugs have asection in the labeling that addresses geriatric use. "There is a need formore inclusion of older adults in clinical trials, especially in the veryold—people 75 and up," Temple says.

In a study published in the Nov. 15, 2004, issue of the Journal of ClinicalOncology, FDA experts analyzed age-related enrollment of cancer patientsinto trials of drugs approved by the FDA from 1995 to 2002. They lookedat data from close to 30,000 people with cancer from 55 trials. Significantunderrepresentation of older people was noted in registration for all cancer treatments except for breast cancer hormonal therapies. People ages70 and older were the most underrepresented group.

Experts say that certain diseases primarily affecting older people, suchas Alzheimer's and Parkinson's, are well studied in older adults. But mostother diseases are not. Barriers to inclusion of older people in clinical trials include logistic challenges that prevent them from getting to clinics.Or there may be criteria that exclude people who take multiple medications and have multiple diseases. ■

with dosing for older people becausethere are not enough clinical trial datain this age group for many drugs, especially in people ages 75 and older.

And because of the use of multiplemedications, drug interactions are ofc o n c e r n . " S o m e i n t e r a c t i o n s a r e n ' t

necessarily harmful and can be easily managed," Setter says. "We wantto prevent drug interactions that aredangerous."

Improving the knowledge base abouthow drugs work together is helpful. Setter says. "We have clinical guidelinest h a t a d d r e s s i n d i v i d u a l d i s e a s e s l i k eAlzheimer 's d isease, Park inson's , ordiabetes. But there is a need for cl inical

guidelines with a geriatric slant—guidelines that can apply to a person whomay have five co-existing diseases."

Drug-drug interactions occur when adrug may increase the effect of anotherdrug or render it ineffective. Paauwsays interactions involving warfarin(Coumadin) are the most commonones that result in hospitalization.Warfarin, a medication that thins theblood and helps prevent clots, is commonly prescribed to older people withan irregular heartbeat (atrial fibrillation) who are at risk of blood clots thatcan cause s t rokes .

W a r f a r i n s h o u l d n o t b e t a k e n w i t h

aspirin, ibuprofen, or other nonsteroidalanti-inflammatory drugs because of theincreased risk of gastrointestinal bleeding. Warfarin also interacts with theantibiotic Bactrim (sulfamethoxazole),which is commonly used in older people.T h i s c o m b i n a t i o n c a n r e s u l t i n s e v e r eincreased bleeding. The supplementsGinkgo biloba, garlic, ginger, and ginseng can also interact with warfarin.

Many interactions can be preventedw i t h m o r e c o m m u n i c a t i o n b e t w e e ndoctors and patients, as well as betterc o o r d i n a t i o n b e t w e e n a l l t h e h e a l t hcare professionals who see a particularpatient, says Nicole Brandt, Pharm.D.,director of clinical and educational programs at the Peter Lamy Center for DrugTherapy and Aging in Baltimore. Sheand her colleagues are partnering witha managed care system to study medication management in older patients whohave been discharged from five hospitals. As part of the study, a pharmacistvisits newly discharged patients to cond u c t a m e d i c a t i o n e v a l u a t i o n .

"The goal is to create a more integrated social and health care support system to improve adherenceand reduce errors," Brandt says. "Ultimately, we want to decrease readmis-sions to the hospital."

Sarah Ray, Pharm.D., ambulatory

clinical coordinator of pharmaceutic a l s e r v i c e s a t A u r o r a H e a l t h C a r e i n

Milwaukee, says that technology isincreasingly playing a role in improving patient safety. "We'll notice ifpatients are discharged from the hospital on a different dose than what theywere on when they were in the hospitalor before entering the hospital," Raysays. "1 then have to clarify with thedoctor, and the prescription may havebeen written incorrectly." Ray says she'sable to catch that k ind of error becauseshe works in an integrated health caresystem and has access to computerizedinformation about what the patientwas taking in the hospital. But thatkind of error might not be caught at anindependent pharmacy that does nothave access to hospital records.

Ray says she thinks electronic prescribing will make a big difference in reducingmedication errors. Electronic prescribing allows doctors to transmit prescriptions to pharmacies electronically. Thismethod decreases errors caused by hard-to-read handwriting and automates theprocess of checking for drug interactionsand allergies. The Medicare PrescriptionDrug Improvement and ModernizationA c t o f 2 0 0 3 e s t a b l i s h e d s t a n d a r d s f o relectronic prescribing. Final standardswill be set by the U.S. Department ofH e a l t h a n d H u m a n S e r v i c e s n o l a t e rthan April 2008. ■

F o r M o r e I n f o r m a t i o n

"As You Age ... A Guide to Aging,Medic ines, and Alcohol"www.fda.gov I cderlconsumerinfo I as_you_age_text.htm

" M e d i c i n e s a n d Yo u : A G u i d e f o rO l d e r A d u l t s "

www.fda.gov/cder/consumerinfo/medAndYouEng. htm

National Institute on Agingwww.nia.nih.gov/

"Saving Money On Prescription Drugs"www.fda.gOv/fdac/features/2005/505_s a v e . h t m l

"Preventing Serious DrugI n t e r a c t i o n s "

www.fda .gov/fdac/features /2004/404_drug.html

26 / FDA Consumer / July-August 2006

Art ificial Sweeteners:No Calor ies . . .

Artificial sweeteners can help consumers cu t down on ca lo r i es and

control weight, help to managechronic conditions such as diabetes, and

potentially prevent cavities, according to theAmerican Dietetic Association (ADA).

h t' ''

To date, five artificial sweeteners are approved by theFood and Drug Administration; aspartame, saccharin,acesulfame-K, neotame, and sucralose. The agency regulatesar t ific ia l sweeteners as food add i t ives, which must heapproved as safe before they can he marketed.

"The FDA evaluates a sweetener's composition and properties, how much of the substance is likely to he consumed,and various types of safety studies," says Laura Tarantino,Ph.D., director of the Office of Food Additive Safety in theFDA's Center for Food Safety and Applied Nutrition.

For each of the approved sweeteners, the typical amountused by U.S. consumers is well within designated "acceptabledaily intake levels (ADI)," or levels that can he consumedsafely every day over a lifetime. Here's a detailed look ateach o f t he swee tene rs .

A s p a r t a m eAspartame is 200 times sweeter than sugar. It has a caloric

value similar to sugar (4 kcal/g), hut the amounts usedare small enough to consider aspartame essentially freeof calories. Brand names include NutraSweet and Equal.Aspartame was first approved by the FDA in 1981 as atahletop sweetener, and for use in gum, breakfast cereal,and other dry products. The use of aspartame was expandedto sodas in 1983, and then to use as a general-purposes w e e t e n e r i n a l l f o o d s a n d d r i n k s i n 1 9 9 6 .

Before approval, the FDA reviewed numerous studiesshowing that aspartame did not cause cancer or otheradverse effects in laboratory animals. "This included threestudies in which rats were fed aspartame in proportionsmore than 100 times higher than humans would likelyconsume," Tarantino says.

In the mid-1990s, a researcher raised concerns that a risei n b r a i n c a n c e r i n c i d e n c e i n t h e U n i t e d S t a t e s w a s l i n k e d

to aspartame use. According to FDA experts, there is noscientific evidence supporting a link between aspartameand any type of cancer. The National Toxicology Program,part of the U.S. Department of Health and Human Services,also conducted aspartame studies in mice and found noc a n c e r l i n k .

In 2005, the European Ramazzini Foundation (ERF)published new findings of a long-term feeding study onaspartame in rats. ERF scientists concluded that aspartamecauses leukemia and lymphoma and that current uses ofaspartame should he reevaluated. After reviewing the studydata, however, the European Food Safety Authority (EFSA)

FDA Consumer / July-August 2006 / 27

Saccharin was discovered in 1879 and is considered generallyrecognized as safe (GRAS) by the FDA.

released a statement in May 2006 that determined to be safe based on proven Committee on Food Additives havesaid the ERF s conclusion was not sup- science. But if new evidence suggests evaluated the sweetener s safety. "Moreported by the data. After learning of the that a GRAS substance may no longer than 90 studies support the safety ofERF study results, the FDA requested be safe, the FDA can prohibit its use or acesulfame-K," Tarantino says,the study data and received a portion require further safety studies,of the data in February 2006. The FDA In 1977, the FDA proposed a ban on Neotamewi l l announce i t s conc lus ions a f te r sacchar in because o f concerns abou t Neo tame i s 7 ,000 to 13 ,000 t imescompleting its review. rats that developed bladder cancer after sweeter than sugar, depending on how

"At this time, our position that aspar- receiving high doses of saccharin. In it's used in food, and has no calories,tame is safe is based on the large body response. Congress passed the Saccha- The FDA approved neotame in 2002 asof information previously reviewed," rin Study and Labeling Act. This leg- a general-purpose sweetener in a wideTarantino says. "Our conclusions are islation put a moratorium on the ban variety of food products other thanbased on a detailed review of more while more safety studies were under meat or poultry. It has been approvedthan 100 toxicological and clinical way. Also, foods containing saccharin for use in baked goods, soft drinks,studies on safety." were required to carry a label warning chewing gum, frosting, frozen desserts.

When ingested, aspartame is con- that the sweetener could be a health jams, jellies, gelatins, puddings, pro-verted in the body to methanol and hazard and that it was found to cause cessed fruit and fruit juices, toppings,two amino acids—aspartic acid and cancer in laboratory animals. Saccha- and syrups.phenylalanine. Tarantino says, "These rin has been the subject of more than Tarantino says that neotame is struc-substances are produced in much 30 studies in humans. turally similar to aspartame. "Thegreater amounts in other common According to the National Can- potential release of phenylalaninef o o d s . " c e r I n s t i t u t e , f u r t h e r s t u d i e s s h o w e d f r o m n e o t a m e i s s o l i m i t e d t h a t a w a r n -

Because of the phenylalanine com- that saccharin did not cause cancer in ing for phenylketonuric-type individu-ponent, aspartame does carry a risk humans, and that the bladder tumors als isn't warranted," she says,for people with the rare genetic disor- in rats were related to a mechanism The FDA reviewed data from moreder phenylketonuria. People who have that isn't relevant for humans. than 100 animal and human studiesthis disorder should avoid or restrict In 2000, the National Toxicology on neotame. These studies evaluatedaspartame use because of their body's Program determined that saccharin cancer-causing, reproductive, and neu-difficulty in metabolizing phenylala- should no longer be listed as a poten- rological effects. "Based on a thoroughnine. Its use can cause phenylalanine tial cancer-causing agent. Federal legis- evaluation of the data, there are noto build up in the blood at higher levels lation followed in 2001, removing the adverse effects anticipated when neo-than normal. The aspartame regulation requirement for the saccharin warn- tame is ingested at levels that are usedrequ i r es t ha t a s t a temen t be p l aced on i ng l abe l . i n f oods , " Ta ran t i no says ,the label of all products containingaspartame specifically to alert phe- Acesulfame-K (potassium) Sucralosenylketonurics of the presence of phe- Acesulfame-K is 200 times sweeter Sucralose is 600 times sweeter thannyla lanine. than sugar, wi th zero calor ies. Brand sugar on average and has no calor ies.

names include Sunett and Sweet One. Although sucralose is made from tableSaccharin Acesulfame-K was first approved by the sugar, it adds no calories because it isn't

Saccharin is 200 to 700 times sweeter FDA in 1988 for specific uses, includ- digested in the body. The brand namethan sugar and has no calories. Brand ing as a tabletop sweetener. The FDA is Splenda. After reviewing more thannames include Sweet'N Low, Sweet approved the sweetener in 1998 for use 110 animal and human studies, theTwin, and Necta Sweet. Saccharin is in beverages. In December 2003, it was FDA approved sucralose in 1998 forused in tabletop sweeteners, baked approved for general use in foods, but use in 15 food categories, includinggoods, soft drinks, jams, and chew- not in meat or poultry. Acesulfame-K as a tabletop sweetener and for use ini ng gum. can be f ound i n baked goods , f r ozen p roduc t s such as beve rages , chew ing

Saccharin was discovered in 1879 desserts, candies, beverages, cough gum, frozen desserts, fruit juices, andand is considered generally recognized drops, and breath mints. gelatins. In 1999, the FDA allowedas safe (GRAS) by the FDA. By defini- The FDA and the Food and Agricul- sucralose as a general-purpose sweet-tion in the law, a GRAS substance has ture Organization/World Health Orga- ener in all foods. ■a long history of safe use in foods, or is nization (FAO/WHO) Joint Expert

28 / FDA Consumer / July-August 2006

The FDA Approves New Drugfor Smoking Cessation

n May 2006, the Food and Drug Administration approved Chantix (varenicline tartrate)tablets to help cigarette smokers ages 18 and older stop smoking.

The drug received a priority review smoking, is the single most preventable found that approximately 22 percent ofbecause of its significant potential cause of death in the United States and is people taking Chantix, 16 percent ofbenefit to public health. Chantix was responsible for a growing list of cancers as people taking bupropion, and 10 per-reviewed in six months rather than well as chronic diseases including those of cent of people taking placebo were stillthe regular review time of 10 months, the lung and heart," says Scott Gottlieb, smoke-free at the end of the year."says Curt Rosebraugh, M.D., M.P.H., M.D., the PDAs deputy commissioner for The approved course of Chantixdeputy director of the FDA's Office of medical and scientific affairs. "The agency treatment is 12 weeks. Rosebraugh saysDrug Evaluation II. "Chantix under- is committed to helping facilitate the that for the first three days, patientswent priority review," Rosebraugh says, development of products to help people take 0.5 milligram (mg) once a day,"because at the time the application quit smoking and improve their overall followed by 0.5 mg twice a day for thewas filed, a preliminary review of the quality of l i fe." next four days, and then 1 mg twiceefficacy studies indicated that smok- The effectiveness of Chantix in smok- a day for the remainder of the treat-ers treated with Chantix may have a ing cessation was demonstrated in six ment period. Patients who successfully

Chantix acts at sites in the brain affected by nicotine ...

superior rate ofsmoking cessation com- clinical trials, which included a total quit smoking during Chantix treat-pared to Zyban (bupropion), another of 3,659 chronic cigarette smokers who ment may continue with an additionalcurrently approved product for smok- were treated with varenicline. Five of 12 weeks of treatment that furthering cessation." the six studies were randomized, con- increases the likelihood of long-term

Chantix acts at sites in the brain trolled clinical trials in which Chantix smoking cessation,affected by nicotine and may help those was shown to be superior to placebo "Cigarette smoking is a very difficultwho wish to give up smoking in two in helping people quit smoking. These habit to break due in large part to nic-ways; by providing some nicotine effects smokers had previously averaged 21 otine dependence or addiction," saysto ease the withdrawal symptoms and cigarettes a day for about 25 years. Steven Galson, M.D., director of theby blocking the effects of nicotine from In two of the five placebo-controlled FDA's Center for Drug Evaluation andcigarettes if they resume smoking. Rose- studies, Chantix-treated patients were Research. "Chantix therapy has provenbraugh says, "If someone slips up, they also more successful in giving up smok- to be effective in smokers motivated towould probably not have the reinforce- ing than patients treated with Zyban. quit and will provide another tool forment that they would normally get from "Both studies had very similar results physicians to use for the millions ofsmoking a cigarette." with approximately 44 percent of peo- smokers who want to quit."

According to the Centers for Disease pie taking Chantix having stopped In clinical trials, the most commonControl and Prevention (CDC), an esti- smoking at the end of 12 weeks, com- adverse effects of Chantix were nausea,mated 45 million adults in the United pared with 17 percent of people who followed by changes in dreaming, con-States smoke cigarettes, and more than were taking placebo and 30 percent of stipation, gas, and vomiting.8 million of them have at least one seri- people taking bupropion," Rosebraugh Chantix is manufactured and distrib-ous illness caused by smoking. says. "Researchers followed study par- uted by New York-based Pfizer Inc. ■

"Tobacco use, particularly cigarette ticipants in both studies for a year and

FDA Consumer / July-August 2006 / 29

Protect ingt h e P u b l i c H e a l t h :

More Than a Full-Time Jobfor Many at the FDA

By Linda Bren

" ach workday, about 10,000 employees of the Food and Drug Administration—" scientists, engineers, physicians, investigators, educators, administrators,_ attorneys, and others—help make a difference in the health and well-being

of Americans.

When their workday ends, many FDA employees volunteer at jobs that promote public health in their local communities, other parts of the United States, or around theworld. "The people at the FDA are committed and dedicated to serving the public,"says Janet Woodco*ck, M.D., deputy FDA commissioner for operations. "They arepassionate about making a difference, even beyond their work at the FDA."

Woodco*ck says the agency encourages volunteerism. "Our people enrich others' livesand they are also enriched personally and professionally through volunteer work. Inaddition to providing a valuable service to a community, many of them bring backknowledge and new experiences that help them in their jobs at the agency."

FDA employees dedicate their time to a variety of public health services ranging frompromoting AIDS awareness in an urban California community to treating malaria inthe poorest country in the Western Hemisphere.

Here are some of their stories ...

30 / FDA Consumer / July-August 2006

Br ighter Smi les in E l Sa lvador■ or two weeks each summer, Susan■ Runner, D.D.S., chief of the FDA's

Denta l Dev ices Branch, leavesb e h i n d h e r a i r - c o n d i t i o n e d o f fi c e i n

Maryland to do dental work in 90-degree heat in El Salvador. Each yearsince 2003, Runner has taken a dental

delegation of several people to helpher, along with 10 suitcases full ofd o n a t e d d e n t a l c a r e m a t e r i a l s .

"The first year, 1 found two volunteerswho agreed to be my dental assistants;a retired lawyer and a retired special edteacher, both fluent in Spanish. Someyears, I've had teen-agers who were flu

ent in Spanish acting as my assistants."We usually stay in a village called

Aguaje Escondido. I set up my clinic ina little building called the dispensary.Villagers come there to see thepromotoras, health workers who haveb e e n e d u c a t e d i n b a s i c h e a l t h a n dfirst aid. There is no access to regularmed ica l ca re o r den ta l ca re .

" W e e a t w i t h t h e f a m i l i e s a n d l i v ewith the families. They're incrediblepeople to be able to open their homesto us. They don't have very much, butthey share with us what they do have.

" O f t e n t h e h o m e s h a v e d i r t fl o o r s

and are made from cinder block or clay.I t ' s l i k e t h e i n s i d e i s o u t s i d e . T h e r e ' sno glass on the windows, and the roofdoesn't meet the ceiling. Some are onlytwo-room homes. It's not private. Oftentimes, bathing is a communal activity inthe pila, a big wash basin outside whereyou wash clothes, dishes, and yourself.You wear a bathing suit, and dip waterand throw it over your head.

" W e w o r k f r o m a b o u t 7 : 3 0 i n t h e

morning till about 5:00 at night, seeingabout 25 patients a day. Most of the villagers have never seen a dentist before.We do a lot of extractions of badly

S u s a n R u n n e r

Susan Runner, D.D.S., examines a patient's teeth in Aguaje Escondido, El Salvador, while her dental assistant looks on. Fortwo weeks each summer. Runner, chief of the FDA's Dental Devices Branch, uses her dental skills to improve oral hygienein the small village.

FDA Consumer / July-August 2006 / 31

S u s a n R u n n e r

'We eat with the families and live with the families,' says Susan Runner, D.D.S., chief of the FDA's Dental Devices Branch.Runner stays in a home like this one while doing volunteer dental work in El Salvador.

decayed teeth, but we also do manyrestorations. The people have a veryhigh carbohydrate-based diet, a lot ofsugar, a lot of sucking on sugar cane, sothere's a high rate of tooth decay.

"You could probably spend a wholeweek restoring some of the mouthsthat we see. We want to see as manypatients as we can, so we have to treatjust the most troublesome or painfulconditions. The people are incrediblygrateful for anything that we do, or thatsomebody would care enough aboutthem to be there at all. We give themtoothbrushes and toothpaste and basicoral hygiene instructions. They lovehaving a brand new toothbrush.

"The kids are really quite brave. Allthe work is done under local anesthesia, so they're totally awake. When youhave an extraction, it's not sharp painbut it's a lot of pressure, which can bescary for many children and adults. It'ssometimes even scary for my assistants

because they are not formally traineddental assistants. They have a hard timewith the blood at first, but they get usedto it. By the time our two weeks are up,I have all my assistants doing cleaningsand giving oral hygiene instructionst h e m s e l v e s .

"There was one young woman whowas one of the most beautiful womenI've ever seen. But when she opened hermouth, 1 saw that her entire upper setof teeth were riddled with decay—justthe most horrible thing. I was able tor e s t o r e a l l o f h e r s i x f r o n t t e e t h w i t htoo th -co lo red res in ma te r ia l . Whenwe finished and she looked at herselfin the mirror, she said, 'I had neverthought I would ever have a beautifulsmile again. Thank you so much forproviding this.'

"The people are desperately poor,but have joy in their lives, which theyshare with us. They also have plans fortheir future, which is why they are so

happy that we can help provide oralh e a l t h c a r e .

"People ask me, 'Is it a vacation?'It's not a vacation. It's very hard livingthere. The running water and electricity don't work consistently. It's veryhot and humid. I don't have a dentalchair. X-rays, or good lighting. If I'mworking on somebody's upper teeth,their head has to be in my lap becauseI'm sitting on a card table chair andmy assistants have a flashlight to shinein their mouth and a little syringe toirrigate with.

"But you're basically doing what youlove to do, you get appreciation for it,and you feel like you're helping otherhumans on earth. We're all part ofhumanity. There's very little you cando to change the whole world, but ona one-on-one basis, you can developrelationships that I think make thingsa little better for humanity." ■

32 / FDA Consumer / July-August 2006

Diagnosis; Diabetes

B l a c k S t a r / D e n n i s B r a c k

FDA endocrinologist ilan Irony, M.D., teaches diabetes management to newlydiagnosed patients at a community hospital in Bethesda, Md.

Ian irony, M.D., is an endocrinologisti n t he FDA ' s D i v i s i on o f Me tabo l i sm

and Endocrinology Products. Mismain focus is diabetes, which affectsnearly 21 million Americans and isthe sixth leading cause of death in theUnited States. Since 1999, Irony hascontributed his time educating peoplewho have been newly diagnosed withdiabetes. He teaches part of a two-dayclass on diabetes management offeredthroughout the year at Suburban Hospital in Bethesda, Md.

"I teach the first portion of the course,an introduct ion to diabetes. 1 talk aboutthe physiology involved, normal andabnormal insulin metabolism and glucose metabolism, types of diabetes,treatments, and complications. Youcan talk for years on diabetes, but eventhough it's just a two-day course, it's agood overview for patients to help themunderstand how to care for themselves.It covers many topics and includes a lecture and hands-on cooking demonstration from a dietitian, foot care information from a podiatrist, blood glucosemonitoring, and more.

"Each class has about 30 patients.Often, their families come with them.We are starting to see more teenagers—about one-fifth of the patientsare teen-agers.

"There are lots of questions. Peoplewant to know, 'Do I have the rightdiagnosis? Do I really have diabetes?Do I have the right medication?'At thepoint that they come to the class, thediagnosis is still relatively fresh and it'shard for them to accept and comprehend. They don't usually have a verygood idea of what diabetes is, or thatthey can still lead a normal life andhave a normal life span if they complyw i t h t h e t r e a t m e n t a n d t h e a s s o c i a t e d

lifestyle changes."I try to reassure them. 1 tell them

that coming to the class is a step inthe right direction, but everything thatthey hear is not going to be valid fiveor 10 years from now. They'll want tokeep themselves updated and educatedon the progress of diabetes research

because the knowledge is evolvingand we'll probably have more efficientt r e a t m e n t s a n d s a f e r t r e a t m e n t s i n t h e

coming years."The class benefits both the patients

and the presenters. Because 1 work inthe field, I have a general feel of what'son the horizon in terms of treatmentsfor diabetes. I can't discuss specificproducts in development, but I cangive them a broad view of where the

science is going. There is a lot of hopefor new treatments and diagnostic andmonitoring methods.

"The class gives me a real appreciation for what patients go through—thepsychological aspects as they accepttheir diabetes as a disease. 1 can takethat back to my work at the FDA as adrug reviewer and put those thoughtsinto protocols for testing and development of products.

FDA Consumer / July-August 2006 / 33

"The other doctors in practice whoteach parts of the course also benefit. Itgives them an opportunity to listen topatients to find out exactly what theirconcerns are. As doctors, we tend tothink about measures of glycosylatedhemoglobin and other parameters ford i a b e t e s t h a t a f f e c t t h e o u t l o o k f o r

health. But patients' concerns are moreabout: 'How is it going to limit my life?What type of diet will I be on? How canI fit an exercise program into my dailyactivities with my already stressfullife?' It gives a different perspective toboth the patients and the doctors.

"For anyone who wants to gain a bet

ter understanding and control of theirdiabetes, I would suggest that theylook for classes offered by their localhospital or the American DiabetesAssociation. The cost may be coveredby insurance." ■

S e a r c h a n d R e s c u e F r o m t h e S a d d l e

As a biologist in the FDA's Centerfor Veterinary Medicine (GYM),M iche le McGu inness , Ph .D . ,

spends much of her workweek evaluating new production drugs for poultry.But the weekends are spent with herhorses, training to track down missing people.

McGuinness serves as ass is tan t commander and team training officer forTROTSAR, a volunteer equine searchand rescue (SAR) team that works withthe Maryland State Police. McGuinness

the lost person cannot be evacuatedusing your SAR horse and you can't geta vehicle in or land a helicopter, youmay have to help carry somebody outon a stretcher. They say in Maryland,you're never more than five miles froma road. But five miles is a long way tocarry somebody!

"Our team is cal led out between threeand six times a year. We're supposed tobe ready to deploy within an hour atany time of the day or night with ourhorses. We've already had three SAR

walking frees us up to look for cluesor look for people. We don't have towatch where our feet are going—thehorse is doing that. And they can carrya lot more gear than people can ont h e i r b a c k s .

"When I met Tom, he was wild, sometimes dangerously ill-behaved, andnobody was willing to ride him. I heardTom called 'useless,' but he was all I hadto ride. It was an adventure, Tom and Iworking things out, but we did.

"Tom and I were out riding with my

'My friend wasn't breathing. He looked pretty much dead, allcrumpled up and with a bloodless white face.'

credits her 21-year-old equine partner, Tom, with saving a person's life.And she credits FDA-approved animaldrugs with keeping her partner healthyenough to perform the rescue.

"We ride and train year-round, inall kinds of weather. We have to learnincident management standards, inaddition to search and rescue skills, aspart of the Department of HomelandSecurity mandate for search teams. Wea r e t r a i n e d i n w i l d e r n e s s fi r s t a i d a n dsearch techniques like clue awareness,crime scene preservation, and map andcompass reading. If you're not properlyskilled and trained, you become a liability on a search and rescue mission.

"You're supposed to be in good physical condition and so is your horse. If

missions this year. On the most recentone, a missing plane search, we workedwith the Maryland State Police, GivilAir Patrol, and ground teams. Theplane and deceased pilot were locatedby a ground team. Our TROTSARmounted teams were working up themountain toward the suspected crashs i t e w h e n w e h e a r d t h e fi n d o v e r t h eradio. We were happy to be part of asuccessful mission, although sad forthe pilot's family.

"Horses provide us with a tremendous field of vision. If you're on theground, you can't see anywhere nearwhat we can see from the top of a horse.We can cover large distances withouttiring because the horse is doing thewalking. Having the horse doing the

friend and his inexperienced horsewhen the accident happened. At onepoint, one of the reins got caughtaround the horse's right hind leg.He suddenly exploded into a fury ofpanicked bucking. I've never heardanything hit the ground so hard asmy friend's body smashing onto thatt r a i l .

"My friend wasn't breathing. Helooked pretty much dead, all crumpledup and with a bloodless white face.But there was a pulse, and I was ableto restart the breathing. Eventually myfriend regained consciousness, and Icouldn't find any broken bones. Wewere several miles from a house or aroad, and his horse was long gone. 1had no cell phone service. My friend

34/FDA Consumer/Juiy-August 2006

B l a c k S t a r / D e n n i s B r a c k

was lapsing in and out of consciousnessand stopped breathing again. I had nochoice but to load him onto Tom andt a k e h i m w i t h m e .

"It took us nearly an hour to walkout of the forest. I then had cell phoneservice and called 911. Tom was fabulous, remained calm even when the

LifeFlight helicopter landed in thefield nearby.

"Tom is handicapped. He has arthritis and a heart murmur and when hepushes too hard, I can feel his heartdoing the 'hokeypokey.' A CVM veterinarian was able to give Tom somemitigating drugs that help him keep

going. Those equine drugs restored mypartner's ability to perform, and thatability saved a person's life. It is ironicthat an old, 'useless,' disabled horse ismy furry hero." ■

FDA Consumer / July-August 2006 / 35

Connect ing With the AIDS Communi ty

When Lila Kraai is not workingas a consumer safety technician in the FDA's San Jose,

Calif., office, she is often visiting withpeople who have HIV or AIDS, coordinating AIDS awareness events in thecommunity, or packing donated foodfor delivery to people with AIDS andthe i r f am i l i es . She a l so se rved on San

Jose's Disability Advisory Commissionfor three years. Once a week, after finishing her FDA workday, Kraai vol

unteers at The Neil A. Christie LivingCenter, an educat iona l , soc ia l , andemotional support facility for peopleliving with HIV or AIDS.

"I used to live in a house right downthe block from a funeral parlor. A goodfriend of mine kept going to funeralsf o r h i s f r i e n d s w i t h A I D S . I d e c i d e dI w a n t e d t o fi n d o u t m o r e a b o u t t h e

disease, so that's how I got into thiswork. I've been working to help people with HIV and AIDS for about 10

y e a r s n o w."AtThe Neil A. Christie Living Center,

we visit with newly diagnosed peopleto educa te t hem abou t r esou rces ava i lable in the community. We organizeclasses in English and Spanish that dealwith life issues facing those living withH I V o r A I D S .

"We get doctors who work in theH I V fi e l d t o c o m e i n a n d t a l k w i t h o u r

c l i e n t s a b o u t t h e l a t e s t t r e a t m e n t s .And we provide a meal once a weekso people can meet each other, talkamong themselves, and don't feel asi s o l a t e d .

"Their biggest concern is that theydon't think anybody wants to helpthem. They're afraid that people aregoing to shun them or not accept them.We want to reassure them that they arenot alone and there are many othersgoing through exactly the same thing.The center is a welcoming, safe placewhere nobody judges them, everyone issupportive, and names are not releasedto the outside. The atmosphere is comfortable and a coffee pot and Crock-Potof soup are on all the time. We encourage the clients to share experiencesand we help them figure out how theycan carry on a productive life, andenjoy life.

"We have more men at the centerthan women. The men str ike me as

being pretty strong-willed people, witha positive attitude. They say the disease is not going to beat them—they'regoing to win. But sometimes theydon't. It's sad when we lose somebody.We have a wake at the center whens o m e o n e p a s s e s a w a y.

"I feel a connection with anyone living with a disease or disability. I suffered a stroke when I was five years oldthat affected the left side of my body.I'm blind on the left side of both eyes so1 cannot drive. On nice days, I bicycleto work, then bicycle to the center.

"Sometimes it's hard to go after work.I keep putting off chores that I need todo at home. But when I get there, I'mglad I went. The people are so nice andappreciative. It makes me feel good,whole, and fortunate." ■

Black Star/David Toerge

FDA consumer safety technician Lila Kraai contributes her time to promote AIDSawareness in San Jose, Cal i f .

36 / FDA Consumer / July-August 2006

F r o m M a l a r i a t o M a c h e t e W o u n d s

mountains to their home. They spend ing water over the cooking fire. Hisfive days to see us for five minutes! I arm was black from the forearm down,don't complain anymore back home It was ulcerated and pus-filled. Hiswhen 1 have to stand in line at the phar- grandmother said it had been like thatmacyfor 15 minutes. for three weeks. 1 asked, "Why didn' t

"1 see children who are severely mal- you take him to the hospital?' Thenourished. 1 see kids eating dirt, they grandmother said she was too weakare so hungry. They are real skinny and to carry him all the way to the hospi-have a big belly full of worms. 1 took tab His arm had to be amputated, butmy microscope with me one time. 1 he lived.

Tan Nguyen

FDA pathologist Tan Nguyen, M.D., poses with a young patient (center, in whitedress) after treating her for a severe asthma attack earlier in the day. Nguyenvolunteers h is medical sk i l ls in a rural area of Hai t i .

Tan Nguyen, M.D., is a U.S. PublicHealth Service pathologist in theFDA's Office of Orphan Products

Development in Rockville, Md. Foreach of the past eight years, Nguyenhas spent a week's "vacation" with ateam of 10 volunteers giving medicalcare to people in a rural area of Haiti.The Department of State describesHaiti as the least-developed countryin the Western Hemisphere and oneof the poorest in the world. Nguyenc o n c u r s a n d d e s c r i b e s h i s fi r s t h a n d

experience."Our baggage allowance on the plane

is 140 pounds per person, and everyone is carrying most of this weight inmedications. We go to Leon, a villageway up in the mountains. We set up asmall, dilapidated clinic, and we stay ina little rectory up the street. The parishfather supports us, and we sleep outside on the veranda under mosquitonetting. 1 bring my own sleeping bagand pillow. They feed us mostly riceand beans. Sometimes they throw ina little meat and we try not to guesswhat it is.

"We walk to the clinic, start at 8 a.m.,and work till dark when the last patientof the day is seen. We have some solarlights and running water now, but foryears, we didn't have either. We justused a flashlight when we ran out ofdaylight and a water bucket for handwashing.

"We treat anything from malaria tomachete wounds. We see about 1,000people in five days. 1 usually see about60 or more people per day, for a prec i o u s f e w m i n u t e s e a c h . T h e r e a r e n olab tests, no X-rays, nothing but medications and stethoscopes. We makethe best diagnosis possible by doinga physical exam and using our clinica l sk i l ls .

"The people don't have transportation. Some of the villagers walk 15miles over treacherous mountain trailsto see us. By the time they get to us, it'snight. They sleep outside the clinic, thenext day we see them, and they spendanother two days to go back up the

wanted to see what parasitic diseasesthey have. 1 looked at about 30 stoolsamples from little kids in the village. Every one of them had multipleparasites. We treat all the children andadults in the village with antiparasiticmedications so they don't get anemia. That's probably the biggest healthimpact we make. The teachers come totell us they've noticed a difference inthe kids—they look healthier.

" W e s a w a c h i l d w h o f e l l i n t o b o i l -

"Haiti is an hour and 15 minutes byairplane from Miami, but the country is forgotten. We all realize that wetouch the very top surface of the misery, suffering, and pain. But if 1 cantake care of even a few people, it givesme a sense of peace and happiness.They thank me profusely. You hearthat and can't help coming back. Youimpact the lives of these people—notin a big way that you make them rich,but you make them healthier." ■

FDA Consumer / July-August 2005 / 37

F i r e a n d i c e

As a chemist in the FDA's KansasCity District laboratory, DavidForan analyzes food samples

to help ensure that the public is notexposed to unhealthy levels of meta ls in food . A f te r work , the chemi s t b e c o m e s a c a s e w o r k e r f o r t h e R e dCross year-round, and in the winter,an Outdoor Emergency Care (OEC)technician on the slopes of the localsk i area.

As a caseworker, Foran is ca l ledupon to provide emergency relief afterna t i ona l d i sas te r s . He was on t he fi r s tcommercial flight into New York Cityafter the terrorist attack on Sept. 11,2001, and was part of the relief crewi n F l o r i d a a f t e r H u r r i c a n e K a t r i n a h i tin 2005. Foran a lso works cases c loser

to home, helping families deal withtragedies, such as house fires, in theKansas City area.

"We may get a phone call any time ofthe night. By the time we're called andarrive, the fire department has alreadybeen there, the fire's out, and the family is wondering what to do next. That'swhere we come in. We assess the dam

age, in general, and their immediateemergency needs.

"Sometimes people are in shock. Wehelp them think through the process ofwhat they need to do, and help themmake the phone calls. Some are upsetbecause 'my TV's ruined,' but we don'td e a l w i t h t h a t . W e ' r e c o n c e r n e d w i t hwhether they have the basic emergencyneeds of food, clothing, and shelter. Ifthey don't have a place to stay, we finda hotel for them. If they need food orclothing, we give them vouchers to useat certain participating vendors. Then wego home and get a few hours' sleep beforegetting up to go to work the next day.

Black Star/Craig Sands

David Foran, a chemist in the FDA's Kansas City District laboratory, does volunteerwork as a Red Cross caseworker and as an outdoor emergency care techniciana t a s k i r e s o r t .

" F r o m a b o u t m i d - D e c e m b e r t o m i d -

March, I'm on the ski patrol at a smallski resort north of Kansas City. I doabout one shift every other weekend.What happens on a shift is totallyunpredictable. I could be on the slopesa whole day with nothing at all happening, or there could be five or sixinjuries in an hour. The majority arepretty minor.

"Rarely there's a serious injury whereyou need to get someone Life-Flightedout. But when bad accidents happen,it's usually because they violated theSkier Responsibility Code; for example,they weren't skiing under control. I sawa kid after a 360-degree flip who landeda n d h i t t h e b a c k o f h i s n e c k . H e w a sin a clearly marked area for advancedskiers only, and he was not skiing incontrol. I understand he ended up partially paralyzed.

"In the skiing off-season, I'm one ofthe instructors in advanced first aid. Weare essentially non-urban EMTs—emergency medical technicians. Our medicaltraining puts more emphasis on coldand outdoor environments. Teachingit is a good way for me to refresh. Themedical text is over 700 pages. We covereverything from how the circulatorysystem works, to how to apply a splintto a femur fracture, and much more.Some of it is lecture, but a lot is hands-on training, such as lift evacuation. Wepractice how to get people out of ski liftsif the lifts fail. You have to manuallytake them down with ropes and lines.

"I volunteer because I get a certainenjoyment and satisfaction out of it.You're doing something to help people, they can't pay you back, and youdon't want the payback. It's frustratingat times, but most of the time it's verysatisfying." ■

F o r M o r e I n f o r m a t i o n

www.volunteer.gov/gov/

www.firstgov.gov/Citizen/Topics/Pub l i cSe rv i ce . sh tm l

www.hud.gov/volunteering/

38 / FDA Consumer / July-August 2006

Investigators' Reports

Execut ives Convictedin Device Scheme

wo executives of a Mundelein, ill., company were convicted on April 13, 2006, offraudulently selling uncleared surgical sterilizing devices that led to eye damageand to the loss of sight in one eye for 18 patients.

Ross A. Caputo was the president andCEO ofAbTox, and Robert M. Riley, thevice president of regulatory affairs ofAbTox, when the company received permission to market a small gas plasmasterilizer only for use in sterilizing flatstainless-steel surgical instrumentswithout tubes or hinges. The defendantsinstead marketed a larger, unauthorized

was caused by a harmful copper acetateresidue that remained in the tube of the

ins t rumen t a f te r i t was s te r i l i zed in them a c h i n e .

One hundred sixty-eight of the unauthorized units were sold to hospitalsnationwide, including U.S. Departmentof Veterans Affairs hospitals and othergovernment agencies, with sales total-

tions. The defendants were convicted ofthree counts of wire fraud, four countsof mail fraud, seven counts of sellingan unapproved (adulterated) or mislabeled (misbranded) human medicaldevice, and conspiracy to defraud theFDA. Riley was also convicted of onecount of making a false statement tot h e F D A ,

'These convictions are evidence of FDA's resolve to ensure thesafety and efficacy of human medical devices.'

version of the sterilizer and promotedits use for a wide array of non-stainless-s t e e l i n s t r u m e n t s .

AbTox showed the hospitals that purchased the larger, unauthorized unitsthe clearance letter for the smaller,authorized unit. Because of the wayAbTox marketed them, these larger unitswere used in an unauthorized manner to sterilize complex instruments,including cataract instruments whichhave small tubes that are used to putsolution into a patient's eye. One unauthorized use was to sterilize ophthalmicinstruments that had brass joints whichreacted to the sterilizing agent and created a toxic residue. AbTox knew of thereaction, but did not advise users or seekproper corrective action. The blindness

ing more than $18 million. Hospitals inChicago, Columbia, Mo., and St. Louis,reported to AbTox that their sterilizerwas suspected of causing injuries toseveral patients. The company failed tonotify the Food and Drug Administration about these reports as required.

"These convictions are evidence ofFDA's resolve to ensure the safety andefficacy of human medical devices.Our criminal investigators aggressivelypursue those that endanger the publichealth by manufacturing and sellingunsafe products," says FDA AssociateCommissioner for Regulatory AffairsMargaret O'K. Glavin.

The conviction of the two men is theresult of an investigation conducted bythe FDA's Office of Criminal Investiga-

The defendants face significant penalties including incarceration, fines, andrestitution. Sentencing will be at a laterdate. Two other defendants, Mark E.Schmitt, former director of marketingof AbTox, and Marilyn M. Lynch, formerdirector of clinical services of AbTox,

previously pleaded guilty in the case.The defendants were found guilty

after a nine-week trial In the NorthernDistrict of Illinois as the result of a successful prosecution under the directionof U.S. Attorney Patrick J. Fitzgeraldfor the Northern District of Illinois, inconjunction with the Veterans AffairsOffice of Inspector General, the NavalCriminal Investigative Service, the AirForce Office of Special Investigations,and the FDA. ■

FDA Consumer / July-August 2006 / 39

Take the FDA ConsarDen QciizWhich artificial sweetener approved by the FDA is 7,000 to 13,000 times sweeterthan sugar? Which federal law now reqpires some cold medicines availablewithout a prescription to be kept behind the counter? What is the Snellen EyeChart? To find out how much you know about these and other health-relatedtopics, take our c uiz.Hint; The answers to all of these qyestions can be found in the July-August 2006issue of FDA Consumer (and at the bottom of this page).

1. Although anyone can get seasonal flu, infection ratesare highest irl what population?

a. people older than 65b. people ages 50 to 65c . w o m e n o l d e r t h a n 6 0

d . m e n o l d e r t h a n 6 0e . c h i l d r e n

2. Warfarin is a blood-thinning drug commonlyprescribed to older people. Which of the followingc o u l d i n t e r a c t w i t h w a r f a r i n ?

a. the antibiotic Bactrim (sulfamethoxazole)b. aspir inc. ibuprofend. ginsenge . a l l o f t h e a b o v e

3. Which country is the least-developed in the WesternHemisphere, according to the Department of State?

a. Nicaraguab . H a i t ic. Dominican Republicd. Paraguaye . M e x i c o

4. Over-the-counter cold remedies containingpseudoephedrine are now being kept behind thepharmacy counter because of what law?

a. Federal Food, Drug, and Cosmetic Actb. Food and Drug Administration Modernization Actc. Dietary Supplement Health and Education Actd . P a t r i o t A c te. Federal Anti-Tampering Act

5. Pseudoephedrine is a common ingredient in whattypes of medications?

a. pain relievers and anti-inflammatoriesb. cold, sinusitis, and hay fever medicationsc. anti-depressants and anti-seizure medicationsd. blood pressure medicationse. cholesterol-lowering medications

6. What is the Snellen Eye Chart?a. a series of numbers arranged in columnsb. a series of letters arranged in linesc. a series of dots arranged in patternsd. a series of circles arranged in rows

7. Refractive error is measured in units called:a. digitalsb. digi tsc. dioptersd . d i l a t o r s

8. How many artificial sweeteners are currentlyapproved by the FDA?

a . 2

b . 5c . 8

d . 1 0

9. Which artificial sweetener is 7,000 to 13,000 timessweeter than sugar?

a . a s p a r t a m e

b . s u c r a l o s ec . n e o t a m e

d . s a c c h a r i n

10. Which artificial sweetener carries a risk for peoplewith the genetic disorder phenylketonuria?

a . a s p a r t a m eb . s a c c h a r i nc . a c e s u l f a m e - Kd . s u c r a l o s e

11. How many adults in the United States smokecigarettes, according to CDC estimates?

a . 2 m i l l i o n

b . 1 6 m i l l i o nc . 4 5 m i l l i o nd . 1 0 0 m i l l i o n

A n s w e r s :

3-11 'e ol '3-6 'q-g D'z 'q'9 'q'S 'P'P 'qx 'a'z: '31

40 / FDA Consumer / July-August 2006

Recent s tud ies show you canp r e v e n t o r d e l a y d i a b e t e s .

it's about small steps: losing a small amountof weight, by walking or biking for 30 minutes 5 daysa week and making healthy food choices, can preventor delay type 2 diabetes. In fact, these small stepsworked even better for people over 60 who wereat risk for diabetes than for any other age group.

It's about big rewards: take your first steptoday to live a longer and healthier life. Talk toyour health care provider about your risk fortype 2 diabetes and the small steps you cantake to prevent it. It's not too late!

4 ™small stftps

P r e v e n t > " 3 D i a b e t e s

F o r m o r e i n f o r m a t i o n a b o u t d i a b e t e sprevent ion, cal l 1 -800-438-5383 and ask for

" i t ' s N o t To o L a t e t o P r e v e n t D i a b e t e s "w w w . n d e p . n i h . g o v

A message from the National Diabetes fSducalion Program, sponsored bythe National Institutes of Health and the Centers Cor Disease Control and Prevention.

National Eye Institute

An eye care professional applies eyedrops to dilate a patient's pupils.

DEPARTMENT OE HEALTH & HUMAN SERVICES

Publ ic Heal th Serv iceFood and Drug Administration

HFI-40, RM 15A-295600 Fishers Lane

Rockville, MD 20857

FOAP 8ARRE7WS ISSDUP002R ]STEPHEN BARRETT HOPO SOX 1747ALLENTOWN pa 18105

F i r s t C l a s s M a i lU . S . P O S T A G E

P A I D

Temple Hills, MDP e r m i t N o . 4 0 0 4

FDA Consumer, July-August 2006 · India, follows the expiration of GlaxoSmithKline's patent on its capsule form of the product marketed under the trade name Retrovir. "This is a signiﬁcant - [PDF Document] (2024)

References