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UK Reports Psychiatric Reactions to Weight-loss Drug Rimonabant

side-effects" since June 2006 but it was now upgrading this warning. Any patient who develops depression while on the drug should stop the treatment, the EMEA said in its recommendation.

An EMEA statement said that Accomplia has been authorised in the EU since June 2006 "for the treatment of obese or overweight adult patients".

It noted added that the product information with the drug did carry a warning "that doctors should not prescribe Acomplia in patients with uncontrolled serious psychiatric conditions such as major depression".

After perusal of all the data made available by Sanofi-aventis on the drug's psychiatric side-effects, Agency's Committee for Medicinal Products for Human Use (CHMP) "concluded that the benefits of Acomplia continue to outweigh its risks, except in patients with ongoing major depression or taking anti-depressants".

Sanofi-aventis said Acomplia labelling had been updated based on data from one year of post-marketing experience and five additional clinical trials completed since June 2006.

"With this updated labelling, Acomplia is now contra-indicated in patients with ongoing major depressive illness and/or ongoing anti-depressive treatment," the statement said.

Last month, a committee advising the Food and Drug Administration (FDA) in the United States voted to ban the drug because of an increased risk of suicide


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