Alli and Xenical Revise Safety Labels to Include Liver-Injury Warnings

Last year HealthNews reported that liver injuries were linked to orlistat, a weight-loss drug marketed under the popular brands Alli and Xenical. Today the FDA announced that it will require liver-injury warnings on both these medications.

A review of adverse events associated with orlistat reported between 1999 and 2008 and data on suspected cases of liver injury that have been submitted by manufacturers of orlistat prompted the decision. While liver injury can be rare, users should be aware of symptoms and immediately discontinue use and/or consult a doctor if the following occur during use: jaundice-related yellowing of the skin or whites of the eyes, weakness, dark-colored urine, light colored stools, or stomach pain.

Orlistat works by blocking the absorption of ingested dietary fats. The FDA approved Xenical (orlistat 120mg) as a prescription product in 1999 for the purpose of obesity management, to be taken in conjunction with a reduced caloric diet. The over-the-counter version by GlaxoSmithKline is Alli, also known as orlistat 60 mg, and was approved for use by overweight adults ages 18 and older in 2007, although first year sales did not reach the manufacturer’s projection. According to the FDA, orlistat is currently approved for marketing in 100 countries worldwide.

If you are looking for a weight loss plan that does not include medication like the prescription Xenical or OTC Alli , visit the HealthNews diet pages and test out our Individual Diet Selection tool, which can help find the right diet for you lifestyle.