THE DEXFENFLURAMINE CONTROVERSY: NO EASY ANSWERS.

Abstract

Earlier this year, primary care physicians in the United States found themselves besieged by inquiries from patients about dexfenfluramine, the first FDA-approved drug for the long-term management of obesity. But this first year of the drug's availability in the U.S. was not without controversy. In a recent case-control study that included 95 cases of primary pulmonary hypertension (PPH) from four European countries, the risk for PPH was significantly increased among users of appetite suppressants -- mostly dexfenfluramine and fenfluramine -- during the previous year (odds ratio, 10.1). The odds ratio climbed to 23.1 when these drugs were used for more than three months (N Engl J Med 1996; 335:609). Interestingly, an association between PPH and appetite suppressant drugs was first suspected several decades ago. Moreover, although the recent data were formally published after dexfenfluramine hit the U.S. market, they were well known to the manufacturer and the FDA prior to the drug's approval in …