If approved, FDA scientists said they would require Vivus to train prescribers to educate patients on the pregnancy risks of Qnexa. The drug would only be available from 10 mail-order pharmacies.
Qnexa's other ingredient, phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine.
Fen-phen is just one example in the decadeslong history of failed weight loss drugs, which have continued to pile up in recent years.
Four years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased heart attack and stroke. The drug won approval in 1997 in the wake of the recall of fenfluramine but never achieved widespread use due to modest weight loss and safety concerns. Only 100,000 prescriptions were written in the U.S. during Meridia's last full-year on the market.
Currently there is just one prescription drug on the market for long-term weight loss: Roche's Xenical, which is sold over the counter as alli by GlaxoSmithKline. The drug is not widely used because of modest weight loss results and unpleasant side effects, including gas and diarrhea.
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