Sanofi-Aventis’ Acomplia is back in the headlines after data compiled by UK regulators suggested that the anti-obesity treatment was linked to five deaths.

The Medicines and Healthcare products Regulatory Agency has posted data on its website which shows that there were 720 adverse event reports filed in the UK between June 2006 and May 2008 related to Acomplia (rimonabant). Of the five fatalities, there were two heart attacks, one case of infectious disease and one sudden death, as well as one case of suicide and two suicide attempts.

Sanofi has responded by saying that most of the deaths happened before 2008 and before the drug’s label was strengthened last year with a further warning for patients with major depression or those taking antidepressants, due to the risk of psychiatric side effects. The France-headquartered drugmaker also noted that the fatalities were in a population that had associated cardiovascular risk factors and not just obesity.

Acomplia (rimonabant) was first approved in Europe in 2006 as an adjunct to diet and exercise for the treatment of obese or overweight patients with associated risk factors such as type 2 diabetes or dyslipidaemia, and was hailed as a potential blockbuster. Since then, however, its progress has been hit with a number of setbacks.

A marketing application was pulled in the USA after it looked unlikely that approval would be granted because of the potential psychiatric side effects and in Europe there have been reimbursement issues, notably in Germany where the Ministry of Health classed Acomplia as a lifestyle drug. Last March, however, UK’s National Institute for Health and Clinical Excellence proposed recommending its use on the National Health Service.