Wyeth-Ayerst Recalls Redux And Pondimin

16 September 1997

Wyeth-Ayerst Laboratories, a unit of American Home Products, hasvoluntarily recalled the troubled antiobesity drug Pondimin (fenfluramine). The company says that, in light of new reports, it has also withdrawn Redux (dexfenfluramine) which was licensed from Interneuron Pharmaceuticals and developed by French firm Servier. The latter is also withdrawing the drugs in Europe.

This action is the culmination of events which began when researchers from the Mayo Clinic reported that 24 patients, who had taken a combination of fenfluramine and phentermine for an average of one year, had developed valvular heart disease (Marketletter July 21).

New Data From The FDA Reports of abnormal heart valve findings continue to be received by both the companies and the US Food and Drug Administration (Marketletter September 8). Most recently, the FDA presented new findings of abnormal echocardiograms in patients with no symptoms of heart valve disease. These patients had received either fenfluramine or dexfenfluramine, most often in combination with phentermine, for up to two years.

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