Citing serious health risks, drug companies pulled two of the most popular diet drugs off the market yesterday.
The Food and Drug Administration found that Dexfenfluramine, sold as “Redux,” and fenfluramine, one half of the “phen-fen” combination and sold alone as Pondimin, had caused heart lesions that could indicate weak heart valves in 30% of the patients who took the drugs. Three deaths have already been linked to the drugs. Other health problems reported include shortness of breath, chest pain, fainting, and heart murmurs. “This is one of the most serious incidents of drug injury that we’ve had in recent years,” said Thomas J. Moore, senior fellow in health policy at George Washington University Medical Center.
Manufacturer Wyeth-Ayerst has sent letters to almost half a million physicians and pharmacists asking them to stop all prescriptions, and will put full-page notices in newspapers nationwide. They have also recalled the drugs in Mexico, Canada, and Columbia. Wyeth-Ayerst Vice President Marc Deitch estimates about 600,000 patients are currently taking one of the drugs, and 2 million others have taken them in all.
Unlike amphetamine-based diet pills, Redux and Pondimin work by altering the brain’s serotonin levels to make the person feel full.
Frank Clemente of Public Citizen’s Congress Watch said that this health scare should cause Congress and the public to think twice about the current FDA reform legislation, because it will give the FDA less control over companies marketing their drugs for unapproved uses.