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There were skeptics even then. The little capsules, they warned, were only a stopgap, not the final answer to obesity, which is still handled best by eating less and exercising more. They also pointed to unknown dangers from long-term use as well as evidence suggesting a risk of neurological damage and a rare but fatal lung disease.
These cautionary words were all but lost in the hype surrounding the FDA's approval of Redux in April 1996 (after a scientific advisory panel initially voted 5 to 3 against approval). By June, U.S. doctors had scribbled nearly 2.5 million prescriptions for Redux, and the number of people exposed to the drugs rose to an estimated 60 million worldwide.
Then the bubble burst. In July, Mayo Clinic doctors reported finding serious heart-valve damage in 24 fen/phen users. Several had to have valves replaced. Alarmed by the Mayo reports, other doctors began looking more closely at their fen/phen patients and found similar problems. The FDA sent a warning to physicians but stopped short of further action. Barely two months later, heart-valve problems were reported in 30% of 291 patients taking fen/phen or Redux, and the agency asked the companies to recall the drugs.
So who's to blame? The correct answer is, all of the above.
--By Frederic Golden. Reported by William Dowell and Jane Van Tassel/New York and Dick Thompson/Washington