Xenical orlistat regulatory update

EMA's CHMP concluded that the benefits of orlistat-containing medicines for obesity outweigh the potential risks of severe liver injuries. The committee found no strong evidence that orlistat increased the risk of severe liver injury. CHMP also said there was no known mechanism by which orlistat was expected to cause liver disorders. The committee concluded the number of reported severe liver reactions in orlistat users was low and below the expected background rate. CHMP recommended the product information for orlistat-containing drugs be "harmonized" to ensure the information on possible very rare liver-related side effects is the same for all drugs.

EMA began the review last August after identifying 21 suspected cases of hepatic events, of which 4 were cases of severe liver toxicity, in patients receiving orlistat during 2009-11. Roche markets 120 mg Xenical orlistat for prescription use, while GlaxoSmithKline markets 60 mg orlistat as alli as an OTC product (see BioCentury, Oct. 3, 2011). ...