Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical): "FDA is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli.
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. Currently, orlistat is approved for marketing in approximately 100 countries. In January 2009, a nonprescription version of orlistat was approved for sale in the European Union.
Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA’s Adverse Event Reporting System. Thirty of the 32 reports occurred outside the United States. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalization was reported in 27 of the 32 cases.
In addition to the 32 reported cases, this issue was discussed at the CDER Drug Safety Oversight Board in April 2009, and FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat. FDA’s analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time."
