Herbal Spotlight
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 orlistat |
| Xenical, Alli (OTC) |
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Pharmaceutical
company:
Roche Laboratories, Inc.
www.rocheusa.com |
NEW WARNING
The Food and Drug Administration (FDA) is reviewing new safety information after receiving reports of liver-related adverse events in patients taking orlistat. Orlistat is sold in the United States as the prescription product Xenical and as the OTC product Alli. Xenical is indicated, in combination with a reduced-calorie diet, for obesity and to reduce the risk of weight gain after prior weight loss. Alli is indicated for weight loss in overweight adults in combination with a reduced-calorie, low-fat diet. From 1999 through October 2008 there were 32 reports of serious liver injury, including 6 cases of liver failure in patients taking orlistat. The most commonly reported adverse reactions included abdominal pain, jaundice, and weakness.
The FDA is currently reviewing information from manufacturers of orlistat concerning suspected cases of liver injury. Currently a direct link between orlistat and liver injury hasn't been identified. The FDA is recommending no changes to prescribing or product use information for either product at this time. However, patients are advised to report signs of liver injury, such as weakness, fatigue, fever, jaundice, brown urine, abdominal pain, nausea, vomiting, light-colored stools, itching, and loss of appetite, to their health care provider. The FDA urges health care professionals and patients to report adverse reactions from the use of orlistat to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.
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