Acomplia, Weight-Loss Drug, Linked to Deaths and Suicide

Sanofi-Aventist SA’s weight loss medication, Acomplia, which is not available in the United States, has been linked to five deaths and more than 2,000 reports of adverse reactions in the United Kingdom. The drug was rejected by the U.S. Food and Drug Administration (FDA) in June 2006, due to a risk of self harm and suicides, but it was approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) in London approximately two years ago.

One of the five deaths linked to the drug was a suicide, which raises further concerns about the psychiatric side effects of Acomplia. The MHRA conducted a review last year of reported depressive reactions in as many as 10% of patients taking the drug, and added stronger warnings to the labels about psychiatric side effects. Doctors and patients were warned to stop the medication if depression was reported while taking the drug.

In January 2008, the FDA instituted a new policy which requires drug manufacturers to examine whether patients become suicidal during clinical trials before they will approve a medication in the United States. The policy was developed following the discovery that several medications which were given FDA approval could carry an increased risk of suicide, including certain antidepressants and Chantix, a drug designed to help people quit smoking.

According to the National Health Service in England, over 100,000 prescriptions were written for 20-miligram doses of Acomplia last year. Sanofi says that they are working with regulators to continue monitoring the safety of the drug. In addition to the suicide, other deaths associated with the drug included two from heart problems, one from an infection and one sudden death with a cause that has not yet been determined.