Orlistat is in a class of medications called lipase inhibitors. These drugs work by preventing some of the fat in foods eaten from being absorbed in the intestines. The unabsorbed fat is then removed from the body in the stool.
Xenical is a prescription weight loss drug marketed by Roche Laboratories while Alli is an over-the-counter (OTC) weight loss drug by GlaxoSmithKline. The active ingredient in both drugs is orlistat, which blocks the absorption of fat.
Approved in 1999, orlistat became the first nonprescription drug to treat obesity in American adults.
The U.S. Drug and Food Administration (FDA) estimates, that 40 million people, worldwide are taking or have taken Xenical or Alli.
FDA: Alli, Xenical Linked To Liver Damage
2010The FDA has approved a
revised label for Xenical to include new safety information about severe liver injury that has been reported with use. The agency is also adding a new warning to the OTC Drug Facts label for Alli. The new safety information is based on the FDA’s completed review of reports of severe liver injury in patients taking orlistat.
Thirty-two reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA’s Adverse Event Reporting System.
2009The FDA, in August 2009, notified patients and healthcare professionals that it was reviewing new safety information associated with reports of
liver-related adverse events in patients taking orlistat. But the agency had not established a definite link between the drug and liver injury.
2006In 2006, Public Citizen petitioned the
FDA to remove Xenical from the market because of its link to the risk of aberrant crypt foci (ACF), a possible precursor to colon cancer.
Consumer SafetyConsumers should consult their healthcare professional if they devope itching, yellow eyes or skin, loss of appetite, light-colored stools and dark urine as these may be signs of livery injury.
See Also
- Diet Drugs
- Prescription & Over-the-Counter Drugs: Overview