Weight loss drug Alli linked to liver injuries

By Sheilah Downey - sheilahd@foodconsumer.org

The weight loss drug Orlistat, sold as the popular diet drug Alli, is being reviewed by the Food and Drug Administration after reports of liver injuries.

The FDA review includes Orlistat, which is marketed under the trade name Xenical by Roche or as an over-the-counter weight loss drug as Alli, by GlaxoSmithKline.

Xenical was approved as a prescription product by the FDA in 1999 and in 2007 Alli was approved as an over the counter weight loss drug.

Between 1999 and 2008 the FDA has received 32 reports of serious liver injuries in patients taking orlistat. Of those cases, 27 were hospitalized and six resulted in liver failure. The FDA report stated that 30 of those cases occurred outside the United States.

The most commonly reported side effects included jaundice, or yellowing of the skin and eyes, weakness and stomach pain.

The FDA is reviewing additional data by orlistat manufacturers on suspected cases of liver injury.

No definite association between liver injury and orlistat has been found as yet, stated the FDA, and consumers should continue to take it as prescribed or directed. Results of their investigation will be released when the review is completed.

Consumers taking the product who experience adverse symptoms such as weakness or fatigue, fever, jaundice, or brown urine, should consult a doctor, the FDA advised.

Health care professionals and consumers are urged to report suspected side effects from the use of orlistat to the FDA's Medwatch Adverse Event Reporting program.