FDA issues early communication about ongoing safety review of orlistat

FDA is reviewing reports of liver injury in patients treated with orlistat (prescription drug, Xenical; OTC drug, Alli) for obesity management or weight loss.

FDA is reviewing reports of liver injury in patients treated with orlistat (prescription drug, Xenical; OTC drug, Alli) for obesity management or weight loss.

Between 1999 and 2008, 32 cases of serious liver injury in patients taking orlistat were reported to the agency. Of these cases, 27 included hospitalization and 6 resulted in liver failure. Jaundice, weakness, and stomach pain were the most commonly reported adverse events.

FDA’s analysis of these data is ongoing. The agency has advised that healthcare professionals should not change their prescribing practices at this time. Patients taking orlistat should consult a healthcare professional if they experience symptoms associated with the development of liver injury, including weakness or fatigue, jaundice, fever, and brown urine. Symptoms of abdominal pain, nausea, vomiting, light-colored stools, itching, and loss of appetite should also be reported.