The product liability team at law firm Leigh Day & Co has been instructed by a number of claimants who have suffered psychiatric events following their prescription of Acomplia manufactured by Sanofi Aventis. Acomplia ( Rimonabant) is a known as a Cannabinoid receptor antagonist which targets the endocannabinoid system in the brain which plays a crucial role in the regulation of mood, cognition, motivation and emotional behaviour. Studies have shown that altered or over-stimulated EC function contributes to the pathophysiological aspects of alcohol addiction, depression, suicidal behaviour and psychosis.
On the basis of the clinical trials carried out by the manufacturers the Food and Drugs Agency (FDA) concluded that there was a doubling of risk of developing suicidal ideation and/or depression in patients who had no underlying history of depression (patients with a history of depression having been excluded from the clinical trials), and did not approve the drug for the US market. It was however approved for the European Market in June 2006. Marketing authorisation for the drug was however withdrawn by the European authorities in January 2009.
Leigh Day & Co partner Bozena Michalowska-Howells who is co-ordinating the claims said:
“There is strong evidence that the manufacturer Sanofi Aventis was aware of the risks of psychiatric side effects well before it was licensed in Europe. However warnings that depressive reactions may occur in patients who have no obvious risk factors were not given until more than two years after the drug went on to the UK market”
Our clients’ case is that Acomplia was defective for the purposes of the Consumer Protection Act and consequently they suffered debilitating psychiatric effects within a few weeks of taking the drug.
If you are concerned that you or a member of your family may have been affected by Acomplia , we suggest that you consult your GP as soon as possible, or contact the Medical and Healthcare products Regulatory Agency for guidance and advice.
For a free initial consultation about the prospects of bringing a legal claim in this regard, please contact Bozena Michalowska in our product liability department on 020 7650 1311.
Information was correct at time of publishing. See terms and conditions for further details.