Patient Safety Alerts
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Rare Cases of Liver Injury Reported with Use of Orlistat
The FDA has advised consumers and health care professionals about potential rare occurrences of severe liver injury in patients taking orlistat (Xenical, Alli). The agency has identified 13 cases of severe liver injury, 12 of which were reports from outside of the United States; a cause-and-effect relationship of severe liver injury with orlistat use has not been established. People who take orlistat should be aware of the signs and symptoms of liver injury, including itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools.
Possible Fracture Risk with High-Dose, Long-Term Use of Proton Pump Inhibitors
The FDA has warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of proton pump inhibitors. Both the Warnings and Precautions section of the prescription labeling and the Drug Facts label on nonprescription proton pump inhibitors will be revised to address these findings.