The Fen-Phen Saga

Santa Fe, NMIt has been more than 10 years since the fen-phen diet pill was removed from the market due to concerns about fen-phen side effects, but drug makers are still looking for another diet drug to help people lose weight. People who suffered serious heart problems after taking fen-phen pills might be wary about weight loss medications, but that hasn't stopped the drug companies from going ahead with it.

On September 23, 1997, The New York Times ran an article about fen-phen and how the drug fell from grace. The fen-phen craze, which ultimately included approximately six million Americans who took the diet drug, started after one study that included only 121 patients.

The drug was designed by Dr. Michael Weintraub, who thought two weight loss drugs that did not work well might be great in combination. Because the two drugs included in the combination, fenfluramine and dexfenfluramine, had been on the market for two decades, he thought all the side effects were already known. So when his study showed that the people on fen-phen lost an average of 30 pounds with no apparent side effects, he thought he had found a drug to help people with weight loss.

When the study results were published, people looking for help with weight loss flocked to their doctors to demand the drugs. The US Food and Drug Administration then approved the drug for long-term use (the component drugs were approved only for short-term use) with a warning that studies lasted only a year. But then reports came in of patients suffering heart valve problems.

On September 15, 1997, the FDA announced that it had requested a voluntary withdrawal of fen-phen from the market. The move was based on an analysis of data indicating that up to 30 percent of patients who were evaluated by a doctor had abnormal medical test results, a much higher percentage than expected. Those abnormal tests suggested valvular heart disease. Approximately half the women who had the valvular heart disease reportedly had pulmonary hypertension.

Since that time, lawsuits have been filed against Wyeth, alleging patients suffered serious, life-threatening injury as a result of taking the weight loss medication.