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Orlistat (Alli; Xenical), which inhibits gastric and pancreatic lipase and prevents some dietary fat absorption, is one of only a few drugs available for treating obesity. In 2009, the FDA issued a warning about possible association between orlistat use and liver injury. In this population-based study, U.K. investigators used several large databases to assess this possible connection.
During a mean observation period of 9 years, 95,000 patients received at least one prescription for orlistat (median age at first prescription, 48; mean duration of orlistat treatment, 11 months). During the observation period, about 1000 patients suffered “definite” or “probable” idiopathic liver injury; 94 patients experienced liver injury during orlistat tre…