Abbott's weight-loss drug wins FDA battle

[Guest guest]

Abbott's weight-loss drug wins FDA battle

By Bruce Japsen

Tribune staff reporter

Published August 17, 2005

The Food and Drug Administration denied a consumer group's petition

to take Abbott Laboratories' prescription weight-loss drug Meridia

off the market, the company and consumer group confirmed Tuesday.

The FDA found that Meridia's benefits continue to outweigh the

drug's risks for select obese patients.

" This decision is good news for obese patients and their physicians

who are considering pharmacotherapy who may have been alarmed by

Public Citizen, " said Dr. Leonard, Abbott's vice president of

global medical affairs.

Public Citizen lodged its complaint against Meridia three years ago,

alleging the drug contributed to dozens of deaths and more than 400

adverse patient reactions since its launch in 1997.

The drug has been shown to elevate blood pressure in patients,

something Abbott says is clearly spelled out on the FDA-approved

label.

Meridia returned to the spotlight last fall when FDA safety officer

Dr. Graham listed it among five potentially dangerous drugs

the agency needed to review--a list that also included cholesterol

drug Crestor, painkiller Bextra, acne drug Accutane and asthma

medicine Serevent.

Graham's blockbuster testimony last fall before a U.S. Senate panel--

called after a study highlighted risks associated with the arthritis

drug Vioxx--came as Congress first began to consider ways the FDA

could improve its surveillance of drugs after they hit the market.

While the FDA denied Public Citizen's petition, it has been working

with Abbott to improve information highlighting appropriate use of

the drug.

On Tuesday, Abbott said it developed and implemented early this year

a program to reinforce the appropriate use of Meridia " that enhances

materials already in place and includes an educational outreach

program " to physicians.

Abbott and researchers in the medical community say they are happy

the FDA supported Meridia, given the high levels of obesity in the

United States and the few available treatments.

But Public Citizen on Tuesday said the FDA made the wrong call.

" This means the FDA has made another mistake, " said Dr. Sidney

Wolfe, director of Public Citizen's health research group. " A lot of

the people who died from this were very young, in their 20s, 30s and

40s. It is very difficult for the FDA to admit they made mistakes. "

Meridia, which Abbott acquired in a 2001 merger, is most often

criticized for promoting limited weight loss in exchange for

increased risk of high blood pressure, especially in the obese

patients who are likely candidates of the drug.

The drug pulls in about $300 million a year for the North Chicago-

based company--almost 75 percent from sales overseas.

Meridia's FDA-approved labels tout weight loss potential of 4 pounds

in the first month while on a low-calorie diet. The company claims

patients lose more weight over time.

In its statement, Abbott was cautious in its endorsement of Meridia,

saying it has been approved as a safe and effective treatment

for " for people who need to lose 30 pounds or more depending on

height " and " when combined with diet and exercise. "

Abbott said the drug has been " extensively studied in more than 100

clinical trials involving more than 12,000 patients throughout the

world. " About 15 million patients in more than 75 countries have

used Meridia, known in most other countries as Reductil.

Meridia has been controversial since its approval almost a decade

ago. Even the FDA advisory panel voted 5-4 against approval in 1996.

Graham said the FDA should consider whether the drug's benefits

outweigh the risks of high blood pressure and stroke, indicating

patients didn't stay on the drug because of such risks.

" With Meridia, I think seriously we have to consider whether there's

just a need for the product in the first place, " Graham told the

panel.