US FDA reviewing Roche weight loss drug Xenical and OTC alli from GlaxoSmithKline

The US Food and Drug Administration says that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed by Swiss drug major Roche and UK giant GlaxoSmithKline as the prescription drug Xenical and the over-the-counter product alli by GSK.

Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. 30 of the adverse events occurred outside the USA. The most commonly reported AEs included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the agency's Center for Drug Evaluation and Research Drug Safety Oversight Board.
'The issues here are complex, but FDA has benefited from the input of the Board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services,' said Steven Osborne, executive director of the Board.

The FDA's analysis of these data is ongoing, and no definite association between liver injury and orlistat has been established at this time. Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter alli should continue to use the product as directed says the FDA.
A spokeswoman for GSK said there is no evidence the company's drug causes liver injury, noting that it primarily acts on the intestinal tract. She said alli's safety has been studied in more 30,000 patients enrolled in 100 clinical studies. "Liver changes can have many causes," said Debbie Bolding, in a statement, noting that "people who are overweight and obese are predisposed to liver-related disorders."

The FDA first approved Xenical in 1999 and alli in 2007. The prescription pill is twice as potent as alli, which can be bought over the counter. GSK reported revenues of $123 million for alli last year, while Roche posted sales of $472 million for Xenical.