Regulatory News In Brief

The benefits of weight loss drugs containing orlistat – including GlaxoSmithKline Inc.’s OTC alli – outweigh their risks, the European Medicines Agency says. There is “no strong evidence” that orlistat increases risk of liver injury and “no known mechanism” by which the drug is expected to cause liver disorders, EMA said in a Feb.16 release. EMA started the review in August at the request of the European Commission after “spontaneous reports of liver injuries.” The agency recommend uniform labeling for orlistat products, including generics authorized in some European Union markets, to ensure the warning about liver damage is consistent. FDA investigated the connection between orlistat and hepatitis and added a warning about rare reports of severe liver injury to the drug facts box Also see "FDA Alerts Public To Ongoing Safety Review Of Orlistat In GSK, Roche Drugs" - Pink Sheet, 31 August, 2009.. Most recently, FDA announced it is studying the link between orlistat and kidney stones Also see "FDA Evaluates Alli For Potential Serious Risk Of Kidney Stones" - Pink Sheet, 16 January, 2012..