Sokolove Success Blog – Our Perspective on Legal News that Matters

When you take a weight-loss pill, you expect to lose a few pounds. But losing your liver? That’s not part of anyone’s diet program.

The Food and Drug Administration (FDA) thinks so, too, which is why it recently alerted consumers to the risk of potential liver damage from diet drugs Xenical and Alli. Both products, which contain different strengths of the active ingredient orlistat (Xenical at 120 mg and Alli at 60 mg) are designed to promote individual weight loss by blocking the absorption of dietary fats, thereby reducing caloric intake. The agency is requiring Xenical, a prescription obesity drug, and Alli, an over-the-counter weight loss supplement, to carry new warnings about rare but severe liver injury associated with their use.

The FDA based its warning and label revision on a completed safety review of orlistat that identified 13 reported cases of severe liver injury, one of which occurred in the U.S. and involved Alli. Of those cases, two patients died from liver failure and three required liver transplantation. In August 2009 the agency announced that it was reviewing adverse event reports of livery injury among orlistat users, which included prescription Xenical and over-the-counter Alli. According to the FDA, between 1999 and October 2008 the agency received 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat. All but two incidents took place outside the U.S.

Despite these reports and the new warnings, the FDA cautions that a definitive link between orlistat and severe liver injury has not been established.

More than 40 million people worldwide have used either Xenical or its non-prescription counterpart Alli, which together have racked up millions of dollars in sales. Up until now, these weight-loss aids have been best known for their unpleasant gastrointestinal side effects, which include oily discharge and uncontrollable bowel movements.  But liver damage? That’s far more than any consumer should be expected to bargain for in the quest to lose weight.

Sokolove Law is continuing to investigate claims of serious liver injury associated with both Xenical and Alli.  If you’re interested in working with us to identify and develop these cases, drop me a line.