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Anti-obesity drug linked to deaths

The Medicines and Healthcare products Regulatory Agency has published data showing that five patients have died while taking sanofi-aventis' anti-obesity drug, Acomplia
The Medicines and Healthcare products Regulatory Agency (MHRA) has published data showing that five patients have died while taking sanofi-aventis' anti-obesity drug, Acomplia.

Psychiatric adverse drug reactions, particularly depression, were identified as the main safety issue when the drug was approved for use throughout the EU in June 2006.

Since its launch, there have been 720 reports of adverse reactions, the most common (46 per cent of all reactions) being psychiatric disorders. The MHRA report shows that one of the deaths was the result of suicide. 

Commenting on the MHRA Drug Analysis Print (DAP) report and figures published by Bloomberg, sanofi-aventis said: ìThe report refers to an aggregated periodic update of a MHRA (UK) database; therefore most of the cases have been the subject of previous MHRA periodic update. The five fatal cases mostly occurred before 2008, and included two myocardial infarctions and one sudden death, in a population with associated cardiovascular risk factors in addition to obesity. One patient died as a result of an infectious disease, in addition to the psychiatric case.

"A causal relationship cannot be established. The 720 figure erroneously presented in a Bloomberg article as 'considered to be more serious adverse drug reactions,' actually refers to individual reports received by the MHRA, from the medicine's introduction in June 2006 to May 2008, without consideration of seriousness," the company added.

Following publication of its findings, the MHRA has advised healthcare professionals against prescribing Acomplia to patients with depression.

After psychiatric side effects, the most common adverse reactions reported were nervous system and gastrointestinal disorders. Two patients died from cardiac disorders (a risk linked to obesity), one patient died from an infection, while another died suddenly from an unknown cause.

Acomplia (rimonabant) is not authorised in the US at present after being rejected last year by a panel from the Food and Drug Administration (FDA) amid concerns of increases in psychiatric behaviour.

A similar drug, Taranabant is currently being developed by US company, Merck & Co. Studies have shown the incidences of psychiatric adverse events were greater at higher doses. However, the most commonly reported adverse reactions were gastrointestinal.

4th June 2008

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