Redux Voluntarily Withdrawn at FDA Request

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January 02, 2008 | 6,626 views

On September 15, 1997, The Food and Drug Administration asked pharmaceutical manufacturers to voluntarily withdraw the controversial diet drugs fenfluramine and dexfenfluramine from the market. The agency said that both companies that make the drugs, Wyeth-Ayerst Laboratories, a subsidiary of American Home Products Co. and Interneuron Pharmaceuticals, had agreed to the withdrawal. The FDA did not request the withdrawal of phentermine, a third drug that is popularly used in combination with fenfluramine.

The action is based on findings linking the drugs to heart valve abnormalities. The FDA said in a statement, "These findings indicate that approximately 30% of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms. This is a much higher than expected percentage of abnormal test results."

INSIGHT: Newsletters readers were warned in early July that this was a dangerous drug to be on and should be discontinued. It is sad it took the FDA nearly three more months to have this drug withrdrawn from the market.