European drug regulators recommended that Acomplia, an antiobesity pill from French drug maker Sanofi-Aventis, shouldn't be prescribed for patients with depression or taking antidepressants.
The European Medicines Agency stopped short of suspending the drug but said Thursday that it should carry more stringent warnings to reflect the danger of potential psychiatric side effects.
The warning comes a month after a regulatory panel for the U.S. Food and Drug Administration rejected an application from Sanofi-Aventis to market the drug in the U.S. due to its possible side effects.
The European agency said it was upgrading an existing warning to European Union doctors. Acomplia, which is generically known as rimonabant and is marketed in the U.S. as Zimulti, was authorized for use in Europe in 2006.
Following a study, a European Medicines Agency committee "concluded that the benefits of Acomplia continue to outweigh its risks, except in patients with ongoing major depression or taking antidepressants," the agency said.
WSJ
The European Medicines Agency stopped short of suspending the drug but said Thursday that it should carry more stringent warnings to reflect the danger of potential psychiatric side effects.
The warning comes a month after a regulatory panel for the U.S. Food and Drug Administration rejected an application from Sanofi-Aventis to market the drug in the U.S. due to its possible side effects.
The European agency said it was upgrading an existing warning to European Union doctors. Acomplia, which is generically known as rimonabant and is marketed in the U.S. as Zimulti, was authorized for use in Europe in 2006.
Following a study, a European Medicines Agency committee "concluded that the benefits of Acomplia continue to outweigh its risks, except in patients with ongoing major depression or taking antidepressants," the agency said.
WSJ
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