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ALLI® & XENICAL® (ORLISTAT) - REPORTS OF LIVER INJURY
August 24, 2009. The U.S. Food and Drug Administration notified healthcare professionals and patients that it is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical®, and as an over-the-counter (OTC) product, Alli®. Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA's Adverse Event Reporting System. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice, weakness, and abdominal pain. FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat, analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time. FDA is not advising healthcare professionals to change their prescribing practices with orlistat. Consumers currently taking Xenical® should continue to take it as prescribed and those using over-the-counter Alli® should continue to use the product as directed.
Orlistat is marketed under the trade name Xenical by Roche or over-the-counter (non-prescription) as Alli® by GlaxoSmithKline. Also known as tetrahydrolipstatin, orlistat is a drug designed to treat obesity. Its primary function is preventing the absorption of fats from the human diet, thereby reducing caloric intake. Orlistat is notorious for its gastrointestinal side effects which can include steatorrhea (oily, loose stools) and fecal incontinence (loss of control of bowels).
If you or someone you love developed liver disease after using Alli® or Xenical®, you may be entitled to financial compensation. Please fill out our online form, or call 1-850-444-9500 or toll free at 1-888-839-3775 to discuss your valuable legal rights with one of the experienced defective drug attorneys at our firm.
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Telephone: 1-850-444-9500 | Toll Free: 1-888-839-3775
