The European Medicines Agency (EMEA) said this week a stronger warning is needed on the weightloss drug Acomplia (rimonabant) from sanofi-aventis, which has been linked to an increased suicide risk.
The EMEA said it is especially important the people with ongoing major depression or who are being treated with antidepressants stay away from the drug.
Doctors in the EU have already been warned about this since June 2006 but the agency’s Committee for Medicinal Products for Human Use (CHMP) has now recommended upgrading this warning. Acomplia has been available in the EU since June 2006 as a weightloss aide to be used in conjunction with diet and exercise for the treatment of obese or overweight adult patients.
Psychiatric side effects, in particular depression, were identified as the main safety issue at the time of approval.
They were reflected in the medicine’s product information as a warning that doctors should not prescribe Acomplia in patients with uncontrolled serious psychiatric conditions such as major depression.