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September 23, 2011

EU regulator to review anti-obesity medicines

Quoted from http://www.reuters.com/article/2011/09/22/us-eu-regulator-idUSTRE78L64220110922

EU regulator to review anti-obesity medicines

LONDON | Thu Sep 22, 2011 4:29pm EDT

LONDON (Reuters) - The European Medicines Agency said it would look into anti-obesity medicines that contain orlistat, including Roche's Xenical and GlaxoSmithKline's Alli.

Its move follows some rare cases of severe liver injury that could affect the drugs' benefit-risk profile.

The EMA, the European Union's drug regulator, said the review would include the prescription-only medicine Xenical (orlistat 120 mg), and the lower dose over-the-counter-medicine Alli, as well as other medicines containing orlistat.

The risk of liver reactions was well known, the agency said in a statement on Thursday, and had been kept under close review. Its new probe focused on the strength of evidence relating to severe liver injury.

It said there were 21 suspected cases of liver injury, of which four were severe, reported among patients taking orlistat 120 mg between August 2008 and January 2011.

[Article continues at original source]

Posted at 11:27 AM in Alli, Xenical |

Tags: Alli, drug injury, EMA, EU, European Medicines Agency, European Union, liver injury, orlistat, safety reveiw, Xenical

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