The September issue of la revue Prescrire reports on the results of US FDA evaluation documents pertaining to rimonabant.
Rimonabant is a cannabinoid derivative appetite suppressant, sold as a weight-loss drug, despite its poor efficacy and its many adverse effects. When the European drug regulatory agency authorised its commercialisation, the published trials already showed psychiatric-type adverse effects. The analysis carried out by the FDA confirms that depression and suicidal symptoms are twice as frequent in patients treated with rimonabant compared with the placebo. In the light of this evidence, and taking account of the limited efficacy of rimonabant, the FDA refused to grant it a marketing authorisation in June 2007. The US consumer group Public Citizen campaigned to have rimonabant withdrawn from the European market. However, in July 2007 the European drug regulatory agency merely limited itself to keeping rimonabant on the market with a simple contra-indication for patients suffering from depression or being treated with antidepressants.
The gravity of rimonabant’s neuropsychiatric adverse effects has been confirmed, whereas its cardiovascular effectiveness beyond the loss of a few kilos remains to be demonstrated. It is better not to use this drug.
©Prescrire Septembre 2007
Source: "Rimonabant : suicides et dépressions " Rev Prescrire 2007 ; 27 (287) : 676.
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