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Why Was Fen-Phen Recalled?

Fen-Phen was a once widely-available prescription medication for weight loss. It contained a combination of fenfluramine and phentermine, two weight-loss drugs. The U.S. Food and Drug Administration recalled Fen-Phen and prohibited its sale in 1997, due to its possible side effects.

  1. Evidence

    • A 1997 study conducted at the Mayo Clinic in Rochester, Minnesota, and published in "The New England Journal of Medicine" found that women who took Fen-Phen were at an increased risk for developing heart valve defects that lead to valvular heart disease. This study prompted the U.S. Food and Drug Administration (FDA) to investigate the matter and recall Fen-Phen.

    Identification

    • Valvular heart disease is a condition where the muscles that keep blood flowing in only one direction through your heart become weak and allow blood to leak back into the valves. In patients who developed valvular heart disease, Phen-fen caused or contributed to the defects in the muscles, reports the FDA.

    Risks

    • Risks associated with valvular heart disease include stroke, heart failure, blood clots and sudden death, warns the National Heart Lung and Blood Institute.

    Treatment

    • Some of the patients who developed valvular heart disease from Fen-Phen required surgery to repair the damage to their heart valves, according to the Mayo Clinic study and the FDA.

    Solution

    • If you were among the patients treated with Fen-Phen, talk to your doctor about the risk of valvular heart disease. You may need an electrocardiogram (EKG) test to monitor the electrical activity of your heart, to ensure that it is functioning properly.

    Considerations

    • The FDA determined that the harmful effects of Fen-phen were caused by fenfluramine rather than phentermine. Drugs containing phentermine are still available for sale in the Untied States with a doctor's prescription, but drugs containing fenfluramine are not.

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