Study: Obesity pill linked to severe mental side effects

Sanofi-Aventis SA’s Acomplia obesity pill puts patients at risk of severe psychiatric side effects, according to a report in the UK medical journal The Lancet.

Scientists found those taking Acomplia were more than twice as likely as those taking a placebo to stop treatment because of depression. Obese patients using the drug, also known as rimonabant, were three times as likely as those on a placebo to develop anxiety.

The Lancet study echoes findings in June by a U.S. Food and Drug Administration panel. That group voted against approving what had been the Paris-based drugmaker’s most-promising new medicine because of a possible risk of suicide. The dangers may be even greater in a real-life situation because patients with a history of psychiatric disorders were excluded from the trials, the Lancet report said.

“Taken together with the recent U.S. 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 report.

Astrup’s group analyzed data using information from trials sponsored by Sanofi on more than 4,000 patients receiving either a sugar pill or a 20-milligram-a-day dose of the medicine.

Acomplia, approved in Europe in 2006, isn’t recommended for patients suffering from depression or anxiety.

The full extent of the risks cannot be determined until more data on why patients dropped out of the tests and how they fared afterwards is available, the report said.

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