THE NATION'S NEWSPAPER USA TODAY |
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Diet drugs pulled off market Heart valve damage prompts withdrawal |
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By Nanci Hellmich USA TODAY Two widely prescribed diet drugs were pulled off the market Monday because of a high incidence of heart problems among patients who take them. Wyeth-Ayerst Laboratories announced voluntary withdrawal of fenfluramine, half of the popular combination drug known as fen-phen, and of dexfenfluramine, marketed as Redux, at the request of the Food and Drug administration. The FDA asked for the action late Friday based on a collection of findings from doctors who used echocardiograms to view the hearts of patients taking the drugs. Abnormalities in the valves, which let blood in and out of the heart, were found in 92 of 291 patientes evaluated. The agency recommended that dieters using the drugs stop taking them and contact their doctors. "These (heart-valve) findings call for prompt action," says the FDA's Michael Friedman. |
Wyeth-Ayerst's Marc Deitch says the company agreed. He says the company has set up a panel of experts to thoroughly evaluate the data and recommend additional action. At this time, Deitch says, the company has no plans to reintroduce the medicines. Sales of Redux and fen=phen(phentermine, the "phen" in the combination is not being withdrawn) totaled an estimated 20.6 million prescriptions last year, according to IMS America, a market research firm. Fenfluramine has been on the market for more than 20 years but only became widely popular in the past several years. Redux was OK'd in 1996. The drugs have been the subject of heated controversy in recent months as cases of heart problems began to surface and various studies linked them to disruption of brain function in animals. Some doctors are encouraging patients who've taken the drugs to get echocardiograms. |
The test is expensive, ranging from $500 to $1,000, and some people may have to pay at least part of the cost out of pocket. The decision to halt sales of the drugs hurt two companies' stocks. Stock in American Home Products, parent company of Wyeth-Ayerst, which makes fenfluramine and markets Redux, fell 3.89 to 73.25. Shares of Interneuron Pharmaceuticals, which licenses Redux, slid 1.06 to 16.89. Analysts say prescriptions of the drug already had plunged before Monday's news, but the real danger to the companies is future legal liability. Lawyers started filing suits in July after the heart-valve problems were first reported. Among them: Two San Francisco firms, Arnold Laub and Lief, Cabraser, Heimann & Bernstein, filed one suit against eight pharmaceutical companies involved in making or selling the drugs on behalf of patients nationwide. Original Clipping (Warning: Large File, Long Download Time) Articles Page |