The European Medicines Agency (EMEA) says the weight loss drug Accomplia, which has also been shown to help smokers quit, should not be used by patients who are severely depressed or taking anti-depressants as it heightens the risk of suicide among this group.
Accomplia is made by the French pharmaceutical giant sanofi-aventis; the generic name of the drug is rimonabant. It has been authorized in the European Union since June 2006, to be used in combination with diet and exercise to help obese and overweight patients lose weight. It was not approved as a smoking cessation agent. Clinical trials showed that it could help patients lose 10 per cent of their body weight.
A warning was issued when it was approved by the EMEA informing doctors not to prescribe it to patients on anti-depressants because of risk of psychiatric side effects, and depression in particular. Information accompanying the drug indicated that doctors should not prescribe it to patients with uncontrolled serious psychiatric conditions such as major depression.
This latest warning is an upgrade, issued by the EMEA’s Committee for Medicinal Products for Human Use (CHMP) following one year of monitoring the drug since its approval. The CHMP asked the manufacturer to submit all the information it had on the psychiatric side effects of the drug.
The CHMP panel met last week to review the information on Accomplia’s side effects and concluded that the benefits of the drug still outweighed the risks, but not in patients with ongoing major depression or who are taking anti-depressants. As well as updating the psychiatric side effect information, they also recommended that the warning be upgraded to say that Accomplia should be stopped if the patient develops depression.
A letter is being sent to all doctors telling them about the new warning and suggesting that patients and the people who care for them should be advised of the risk of depression from taking Accomplia.
Last month, the US Food and Drug Administration (FDA) Advisory Committee for Endocrine and Metabolic Drugs (EMDAC) said that sanofi-aventis had failed to show that Accomplia (rimonabant) was safe and voted against recommending the anti-obesity treatment for use in the United States. According to a report in Britain’s Daily Mail, two of the patients in a trial reviewed by the FDA committed suicide and one was suicidal. One of the patients in the trial had also tried to kill his daughter.
Sanofi-aventis withdrew their application for FDA approval of Accomplia and said it would submit a new one in due course.
The body that controls drugs in the UK, the Medicines and Healthcare products Regulatory Agency, up to the end of last month, has received 318 reports of patients being affected by side effects from taking Accomplia. The drug has been on sale in the UK since July 2006. Since then more than 40,000 Britons have used it.
The CHMP recommendation now goes to the European Commission for a final decision.
Accomplia is used by patients who are obese with a body mass index (BMI) greater than or equal to 30 kg per meter squared as part of a program that includes exercise and diet. It is also used by patients who are overweight (BMI of 27 or more) who have other risk factors such as type 2 diabetes or high levels of blood fat.
The active ingredient in Accomplia (rimonabant) is a cannabinoid receptor antagonist. This blocks the cannabinoid type 1 (CB1) receptor in the brain which helps to control food intake. Blocking the receptor makes it easier for patients to stop over-eating. CB1 receptors are also found in fat cells in the body.
For further information please go to The European Medicines Agency.
Written by: Catharine Paddock
Writer: Medical News Today