24 October 2008
The Marketing Authorisation for the diet drug Acomplia
was suspended yesterday following assessments which concluded that there was increased risk of psychiatric disorders in users of the drug.
The European Medicines Agency
(EMEA), the regulatory body with the responsibility for the protection and promotion of public health in Europe, recommended the suspension of the marketing authorisation for the drug, known generically as rimonabant
Warnings about psychiatric side effects have been included in the product infromation for the drug since it was first authorised. Depression, in particular, was considered to be one of the most important safety issues. However, new data from ongoing clinical trials has indicated that serious psychiatric disorders may be more common than initially assessed. As a result, the EMEA’s Committtee for Medicinal Products for Human Use has concluded that the benefits of the drug no longer outweigh the risks.
Doctors have been told to stop prescribing Acomplia, and review the treatment of those patients currently taking the medicine.
Leigh Day & Co’s product liability team has unrivalled experience in dealing with claims relating to defective drugs and medical devices. If you would like to talk to one of our solicitors about a possible claim, please contact Bozena Michalowska
or Jill Paterson
on 0207 650 1200.
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