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The European Medicines Agency wants Sanofi-Aventis SA’s anti-obesity drug Acomplia out of the market after studies showed an increased risk of psychiatric disorder, including suicidal thoughts in patients treated with it, the agency said on Thursday.
Furthermore, the agency released a statement urging doctors to review treatment of patients taking Acomplia, also known as rimonabant, and patients taking the drug to consult their doctors but not necessarily stop taking the drug immediately.
“Prescribers should not issue any prescription for Acomplia (rimonabant) and should review the treatment of patients currently taking the medicine,” the EMEA said in a statement.
Acomplia has been available in Europe since 2006, although it’s not yet available in the US. In 2007, the Food and Drug Administration denied approval of Acomplia in the US, citing safety concerns. The FDA based its decision on studies showing that the drug not only raises the risk of depressed mood disorders and anxiety, but is also almost ineffective against obesity, as people lose less than 5 percent of their total body weight.
Now the European Medicines Agency said it had concluded that the benefits of Acomplia no longer outweighed its risks, and there was an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking Acomplia versus placebo.
On the other hand, Sanofi said it would comply with the EMEA’s decision, but reiterated its belief that the drug could bring significant benefits to obese and overweight people. The company says it plans to continue with late-stage Phase III trials of the drug as a treatment for type 2 diabetes in studies involving thousands of patients.
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