From 1999 to October 2008 the FDA has had reports of 27 cases of hospitalizations and 6 cases in which patients "suffered liver failure" after taking weight-loss drugs made by GlaxoSmithKline PLC and Roche Holding AG. The most commonly reported adverse events included jaundice, weakness, and stomach pain. Glaxo manufactures the over-the-counter drug Alli [orlistat 60 mg], and Roche markets the prescription drug Xenical [orlistat 120 mg]. Consumers are being advised to continue taking the medications as directed but consult their doctor if experiencing any side-effects from orlistat and development of liver injury especially weakness or fatigue, fever, jaundice, or brown urine but also abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite. The FDA has not yet established a direct link between liver injury and orlistat.
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