Obesity :: FDA concerned about Sanofi obesity drug Acomplia

The U.S. Food and Drug Administration said that patients who took Acomplia, also known as Zimulti, in clinical trials were more likely to suffer from suicidal thoughts or actions than those on placebo.

The notes were posted prior to a meeting by US health experts, as is customary, who will on Wednesday decide whether to recommend the drug to the FDA health regulator for marketing approval.

Acomplia or rimonabant (SR141716) is an anorectic anti-obesity drug. It is a CB1 cannabinoid receptor antagonist. Its main avenue of effect is reduction in appetite. Rimonabant is currently being sold in the United Kingdom by Sanofi-Aventis and in Denmark by Sanofi-Synthelabo under the trade name Acomplia. It is believed, although not confirmed, that if the drug is approved in the United States, it will be sold under the trade name Zimulti.

It is being reported that the FDA is concerned over Acomplia due to it appearing to raise a person’s risk of attempting to commit suicide. The drug does actually work according to the FDA who stated that over a 1 year period, when combined with a good diet a person could lose up to 5% more than they would if they just dieted.

The US FDA is set to ask an advisory panel tomorrow to measure the benefits against the risks and decide if the drug should be marketed in the United States.

Sanofi-Aventis (SASY.PA: Quote, Profile , Research) shares fell as much as 1.7 percent on Tuesday as investors reacted warily to a U.S. health review of anti-obesity pill Acomplia, highlighting its side-effects such as suicidal thoughts.


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