Acomplia linked to deaths since approval in U.K.

Sanofi-Aventis' Acomplia weight-loss treatment, rejected last June by a panel of FDA experts, was linked to five deaths in the U.K. since the medicine went on sale two years ago, Bloomberg reported June 3.

There were 720 reports of adverse drug reactions mentioned from use of Acomplia in the U.K., the London-based Medicines and Healthcare Products Regulatory Agency (MHRA) said. Some of the ADRs involved more than one side effect, bringing the total to more than 2,100, Sanofi said. The data, covering reports from the June 2006 introduction to May 9, was released on its Web site.

Five of the cases were fatal, including one patient who committed suicide, according to the report. Individual side effects could be headaches, skin or breathing disorders, or heart issues.

Paris-based Sanofi was dealt a blow a year ago when an FDA panel voted against recommending the pill for approval because of a possible risk of self harm. Sanofi said today that it is monitoring the safety of the product with regulators.

"We are working closely with the FDA to match the requirements," Alexandre Moreau, a Sanofi vice president who oversees the marketing of diabetes products, said in an interview with Bloomberg. "We've been in close contact with them. Acomplia is not for everybody so we're working to identify the right patient target."

The reactions were reported under MHRA's Yellow Card Scheme, which provides a system for early detection of emerging drug safety hazards and routine monitoring for medicines in clinical use. The reports are submitted voluntarily by doctors, nurses, pharmacists, patients, coroners and company officials.

Two deaths were heart related, one involved an infection, another was a sudden death and the final one was a suicide. Most of the data has been reported by the MHRA, which released the cumulative report last month.

"This population has additional health risks, including obesity and cardiovascular risks," Sanofi spokesman Salah Mahyaoui said.

Sanofi doesn't have similar data from other countries, spokesman Jean-Marc Podvin said. The U.K., Germany and France are the biggest consumers of the medicine, according to the MHRA.

The U.K. agency said that depressive reactions may occur in as many as 10% of patients. After regulators reviewed data last year, the pill's label was strengthened to warn about use in patients with major depressive disorder or on antidepressants, and doctors were told treatment should be stopped if patients became depressed.

According to the National Health Service, which provides medical care to citizens in England and Wales, there were 101,000 prescriptions written for the 20milligram dose of Acomplia last year in England. That doesn't include use in Wales, Scotland or Northern Ireland.

U.K. medical advisers backed restricted funding for Acomplia in March, saying the drug shouldn't be used for longer than six months unless a patient lost at least 5% of his or her body weight in that time and not for longer than two years in total without assessment.