Sanofi’s Acomplia Linked To Depression, Again
1 CommentBy Ed Silverman // November 16th, 2007 // 8:16 am
The fat pill, which an FDA panel rejected earlier this year over concerns about psychiatric side effects, is once again being linked to depression. Patients given Acomplia had more than twice the risk of depression and anxiety, according to a meta-analysisr published in The Lancet medical journal.
Danish researchers reviewed four studies featuring 4,105 patients and found that people taking 20 milligrams per day of the drug were 2.5 times more likely to discontinue treatment due to depressive disorders and three times more likely to stop because of anxiety than those given a placebo. The dangers may be even greater during real-world usage, because patients with a history of psychiatric disorders were excluded from the trials. Acomplia was approved in Europe last year, although the pill isn’t recommended for patients suffering from depression or anxiety.
“Taken together with the recent FDA finding of increased risk of suicide during treatment with rimonabant, we recommend increased alertness by physicians to these potentially severe psychiatric adverse reactions,” Arne Astrup, the professor at the University of Copenhagen who led the research, wrote in The Lancet. After the FDA panel gave its thumbs down, Sanofi execs pulled the application, although held out the possibility of resubmitting in the future. But given these findings, fat chance the drugmaker will get an approval any time soon.
» Sanofi’s Acomplia Linked To Depression, Again
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