Word: fda
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Dates: during 1990-1999
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...more in a matter of weeks. And it's not through willpower or exotic diets or Olympian exercise routines, but largely because, for the first time in their lives, they have simply lost interest in eating. The reason for this astonishing transformation: Redux, approved by the FDA last April as the first new diet drug in the U.S. in 23 years...
What Seiden and others claim is that the FDA glossed over evidence that both Redux and the older drug fenfluramine cause significant brain damage in laboratory animals, from mice to baboons. The problem, they say, is that after the drugs are withdrawn, serotonin levels plummet and stay low for weeks at least. The effect is similar to one caused by the recreational drug Ecstasy, a distant chemical cousin of the fenfluramine family, and the cause is evidently the same: neurotoxicity, or more plainly, the killing of brain cells. An overdose of Redux makes the neurons that produce serotonin swell, then...
Then Interneuron went after and got FDA approval--a ruling that critics charge was made with unseemly--and perhaps even unprofessional--haste. Says Lewis Seiden, a University of Chicago pharmacologist who testified before the FDA advisory committee: "The procedures were loose, to be mild about...
This potential danger, when combined with the generally acknowledged risk of pph, was enough to persuade the FDA advisory committee to reject Redux by a 5-to-3 vote on the question of safety when it first came up for consideration a year ago. But a few hours later, FDA official Dr. James Bilstad reopened the discussion after some committee members had left the meeting. Since there was no longer a quorum, a new meeting was called for two months later, in November...
...fast, counters the FDA's Bilstad. Yes, he did reopen the issue after last September's no vote. But that, he says, is because it became clear that the vote to reject was invalid: at least one member had misunderstood the wording of the question on the table. "Obviously," says Bilstad, "we wanted a nonambiguous recommendation from the committee." Some members had left the meeting, though, and without a quorum he couldn't proceed. He considered polling the absentees by phone, but the FDA counsel advised against doing...