The FDA said its regulators are assessing at least 32 reports of liver problems occurred in patients between 1999 and 2008 by taking the weight-loss drug orlistat, sold as a prescription drug Xenical and more recently, as an over-the-counter medication called Alli. Of the 32 reports of liver problems the FDA has in hand, 27 patients were hospitalized and six suffered liver failure. In an “early communication” of a drug safety review, the FDA said it will also review additional data on “suspected cases of liver injury” submitted by drug firms that make and market orlistat in its branded and generic forms.

The Committee for Medicinal Products for Human Use (CHMP) has given positive opinion as a non-prescription product to GlaxoSmithKline’s alli (orlistat 60 mg). This takes the product to the stage of proposal for final approval by the European Commission. A marketing authorization will follow that. On the grant of license, alli 60 mg would become the first aid for weight loss to be available without prescription across Europe. It will be indicated for people above the age of 18 with a BMI more than 28 kg/m2.