The weight-loss drug Acomplia "� made by the French company Sanofi-Aventis "� has been linked to five deaths and 720 adverse drug reactions, according to Britain's Medicines and Healthcare Products Regulatory Agency. The drug (rimonabant) continues to be sold in Britain and other European countries with stricter safety warnings.
Last year, an advisory committee of the Food & Drug Administration in the U.S. refused to recommend the drug for use in the United States. That recommendation is based on FDA findings of an apparent link to suicidal behavior in some Acomplia users during clinical trials.
A final decision by the FDA is expected on July 26. The agency is considered likely to support the recommendation of the advisory committee.
The latest findings may significantly damage the drug's sales overseas.
Sanofi-Aventis is to submit additional data to the FDA before submitting another request for U.S. approval. The process could take several years.
The FDA reported that a 20-mg dose of Acomplia had a statistically significant link to incidences of adverse psychiatric events "� including suicidal thought or behaviour during clinical trials.
The French manufacturer promoted Acomplia as an effective drug to block off brain receptors that control appetite rather than working with the gastrointestinal system, as most weight-loss drugs do.
Despite the adverse findings, the drug has been given regulatory approval in 37 countries and is on sale in 18 of them.
A complete market withdrawal is not considered likely, but the European Medicines Agency could request Sanofi-Aventis for additional safety data on the drug or possibly strengthen the warning level on Acompli's European label.
The Centers for Disease Control & Prevention estimate that 30 percent of adults 20 and older, or 60 million people, are clinically obese, suggesting that the French-made drug may ultimately gain approval in the United States.
Are you considering plastic surgery? If so, please contact a board certified surgeon to become better informed about your options.