FDA Issues Early Communication About Ongoing Safety Review of Weight Loss Drug Orlistat

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The US Food and Drug Administration (FDA) announced that it 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 120 mg) 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 60 mg) was approved for OTC use for weight loss in overweight adults (≥18 years) in conjunction with a reduced calorie, 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 were jaundice, 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 the FDA says it is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat. The agency points out that analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, brown urine, or loss of appetite.

The FDA notes it is not advising health care professionals to change their prescribing practices with orlistat. Consumers currently taking Xenical should continue to take it as prescribed and those using OTC Alli should continue to use the product as directed.

The agency urges both health care professionals and consumers to report side effects from the use of orlistat (both Alli and Xenical) to the FDA's MedWatch Adverse Event Reporting program either online, or by regular mail, fax, or phone: