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FDA approves revised label for orlistat
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The FDA has approved a revised label for orlistat to include new safety information about rare reports of severe liver injury reported with the use of this medication and is working with the manufacturer to ensure that consumers can understand this new warning.
This new safety information was originally announced in August and is based on the FDA’s complete review of the drug. Twelve cases of severe liver injury were reported with orlistat 120 mg (Xenical, Genentech) and one case with orlistat 60 mg (Alli, GSK).
No cause-and-effect relationship has been established between orlistat and severe liver injury; however, because of the seriousness of this possible adverse event, the FDA has revised the drug labels for both forms of the drug to include new safety information about the rare occurrence of severe liver injury.
The agency said health care professionals should weigh the risks and benefits associated with orlistat before prescribing or recommending it to their patients. Conversely, patients should stop the use of orlistat and contact their health care professional if they develop the signs and symptoms of liver injury, including itching, yellow eyes or skin, dark urine, light-colored stools or loss of appetite.
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