The European drug regulator EMEA said Thursday it had maintained authorisation of weight-loss pill Acomplia in the European Union, but had ordered it to be withheld from people suffering from depression.
A panel of experts from the US Food and Drug Administration concluded in June that the dieting treatment, which can also be used to treat diabetes, was unsafe because it caused suicidal thoughts as a side-effect.
AdvertisementThe maker of the drug, French group Sanofi-Aventis, abandoned attempts to win approval for the drug in the United States as a result.
The European Medicines Agency (EMEA) recommended Thursday that Acomplia, also known as Rimonabant, should not be given to patients with depression or those taking anti-depressants because of the risk of psychiatric side-effects.
The agency said that depression was known as the main side-effect of the drug and this had been signalled at the time of its approval in June 2006.
However, the Agency's Committee for Medicinal Products for Human Use (CHMP) had recommended upgrading the warning about depression.
Sanofi-Aventis, the fourth-biggest drug maker in the world, announced afterwards that it had changed its labelling to take into account the EMEA's comments.
The recommendation from the EMEA will be sent to doctors prescribing drugs in the countries where the drug in being sold.