Jun 24 2008
A controversial diet drug has been approved for use on the National Health Service (NHS) in Britain.
The obesity drug, Rimonabant also known as Acomplia, has been linked to an increased risk of depression and suicide and is not recommended for people who are depressed.
The drug is already used by thousands of Britons, and along with a physical exercise programme can help obese patients lose up to 10% of their body weight.
In 2007 the European Medicines Agency warned that Rimonabant may be unsafe for patients also taking anti-depressants, and the National Institute for Health and Clinical Excellence (NICE) supports that advice.
The Food and Drug Administration (FDA) in the U.S. are yet to approve the drug also because of safety concerns.
Obesity experts say Rimonabant is a good drug which has worked for many people who have found little success with other drugs and treatments.
However doctors have been advised not to prescribe the drug to patients with a history of major depression, and to be alert for new symptoms of depression in patients taking the drug.
Acomplia will only be available on the NHS for those who have tried and failed using alternative drugs such as orlistat and sibutramine.
Evidence from research suggests that one in 10 people might develop mental side-effects including low mood and depression, anxiety, irritability, nervousness and sleep disorders.
These risks of course have to be balanced against the benefits of weight loss such as improved general health, lower blood pressure and cholesterol levels.
Acomplia first became available in the UK in 2006, and since then, the Medicines and Healthcare Products Regulatory Agency has received 720 reports of adverse drug reactions, covering 2,123 individual reactions.
Of these, 974 involved psychiatric disorders, including 48 reports involved suicidal thoughts, and a total of 93 involving depression.
Five resulted in death, one suicide, one from infection, one sudden death from an unknown cause and two heart attacks.
A review of trial evidence last year also found evidence that depression and anxiety were more likely in patients taking the drug.
Worldwide Rimonabant is most in demand in Britain, Germany, and France and is not currently available in Australia.