A weight-loss drug that doubles the risk of psychiatric disorders should no longer be prescribed, according to the European Medicines Agency (EMEA).
It has recommended that Acomplia’s marketing licence be suspended and that healthcare professionals should not give any new prescriptions.
Sanofi-aventis – which manufactures Acomplia – has agreed to comply with the recommendation immediately. Patients will have their treatment reviewed and should contact their doctor or pharmacist.
Acomplia is a brand name for rimonabant, an appetite suppressant that is also used to help overweight patients who have type 2 diabetes or who have abnormal levels of fat in their blood (dyslipidaemia).
The EMEA said its committee for medicinal products for human use “has concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union”.
The panel then confirmed “that there is an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking Acomplia compared to those taking placebo”.
These disorders include depression, sleep disorders, anxiety and aggression.
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