Xenical (orlistat 120mg) was approved as a prescription product by FDA in 1999 for obesity management in conjunction with a reduced caloric diet, and to reduce the risk of regaining weight after prior weight loss. In 2007, Alli (orlistat 60mg) was approved for OTC use for weight loss in overweight adults, 18 years and older, in conjunction with a reduced-calorie and low-fat diet.
FDA Drug Safety Communication: Completed safety review of Xenical/Alli (orlistat) and severe liver injury[ARCHIVED]
Questions and Answers: Orlistat and Severe Liver Injury[ARCHIVED]
Weight-Loss Drugs and Risk of Liver Failure[ARCHIVED]
FDA consumer update
UPDATED Public Health Alert: Counterfeit Alli containing sibutramine[ARCHIVED]
Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)[ARCHIVED] Issued 8/24/2009