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An FDA advisory panel voted on Tuesday to approve a new diet pill — a combination of the antidepressant bupropion and the anti-addiction drug naltrexone (brand name, Contrave) — the Associated Press reports.
A majority of the panel also asked for postmarketing research to investigate any potential heart risks, citing a lack of data on the combination's use in elders with a history of heart disease.
In studies of the pill, weight loss was, on average, 4.2% greater with bupropion/naltrexone than with placebo — not quite meeting the FDA's guideline for at least a 5% difference — according to the AP.
The agency is expected to make a decision early next year.
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LINK(S):
Associated Press story (Free)
Manufacturer's press release (Free)
Journal Watch General Medicine summary of phase III study on bupropion/naltrexone (Free)