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History

Fenfluramine was first introduced in the 1970s, but was not popular because it only temporarily reduced weight by a few pounds. It was modestly selling until the 1990s when it was combined with phentermine and heavily-marketed. A similar drug, Aminorex, had caused severe lung damage and "provided reason to worry that similar drugs ... could increase the risk of a rare but often fatal lung disease, pulmonary hypertension". In 1994, Wyeth official Fred Wilson expressed concerns about fenfluramine's labeling containing only 4 cases of pulmonary hypertension when a total of 41 had been observed, but no action was taken until 1996. Wyeth introduced Redux (dexfenfluramine, the dextro isomer) in 1995 which it hoped would cause fewer adverse effects. However, the FDA's medical officer Leo Lutwak insisted upon a black box warning of pulmonary hypertension risks. After Lutwak refused to approve the drug, FDA management had someone else sign it and approved the drug with no black box warning for marketing in 1996. European regulators required a major warning of pulmonary hypertension risks. Read full entry

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