Americans hoping to trim the fat by popping a pill have been wondering when and if the weight loss drug Acomplia will hit the U.S. market. But recent findings by the U.K.'s drug regulator--the Medicines and Healthcare Products Regulatory Agency--might prevent the drug from receiving approval in the States. The regulator says the drug, made by Paris-based Sanofi-Aventis, has been linked to five deaths and 720 adverse reactions since the company launched it in Britain two years ago. The report looked at morbidity and mortality in association with the drug through May 9, 2008.
About a year ago, the FDA rejected the drug--also known by its generic name, rimonabant--saying it raised the risk of depression and suicidal thoughts among users. In fact, the British regulator found one case of suicide and two additional attempts among users. Sanofi-Aventis plans to resubmit the drug to the FDA in 2009 as a diabetes treatment option. Overall, there have been five deaths--one by suicide, two with fatal heart attacks, one sudden death and one by infectious disease--among patients taking Acomplia.
The multimillion-dollar drug remains available abroad, but now has stronger warnings on its labels. Acomplia showed sales of $122.8 million in 2007.
At the same time, Merck is pushing ahead with development of taranabant, its version of an anti-obesity drug. The drug, which has a similar mechanism of action, also has shown psychiatric side effects including depression, anxiety and irritability. The report on Acomplia is likely to raise concerns for both companies.