French drug major Sanofi-Aventis' obesity drug Acomplia (rimonabant) has been linked to five deaths and 720 adverse drug reactions in Britain since its launch two years ago, according to reports collected by the UK regulator.
This is the latest setback for the predicted blockbuster. A US Food and Drug Administration panel voted against approving the drug due to concerns that it doubles the rate of suicidal ideation and behavior (Marketletter July 9, 2007) and the European Medicines Agency (EMEA) added warnings to the Acomplia label to reflect the risk of psychiatric side effects (Marketletter July 30, 2007).
Figures revealed on the Medicines and Healthcare Products Regulatory Agency's (MHRA) web site show that there was one case of suicide in the period up to May 9 and two suicide attempts since it was approved two years ago (Marketletter July 3, 2006). In a statement to the Marketletter, the Paris-headquartered firm noted that the figures refer to an aggregated update and, as such, most of the cases have been the subject of previous disclosure.
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Chairman, Sanofi Aventis UK
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