FDA adds liver injury warning to label of Roche's Xenical, GlaxoSmithKline's Alli

In a notice posted to its website Wednesday, the FDA reported that it approved label changes for Roche's Xenical (orlistat) and GlaxoSmithKline's lower-dose, over-the-counter version, Alli, to include a warning about rare reports of liver injury among users of these drugs.

The agency's decision to update the label was based on a review of all available clinical trial, postmarketing, and drug utilisation data, which identified 12 reports of severe liver injury among people using Xenical and one report in Alli users between April 1999 and August 2009. In two cases, the liver injury proved fatal, and in three others, a liver transplant was required. While US regulators noted that "at this time, a cause and effect relationship of severe liver injury with orlistat use has not been established," the FDA opted to add the information due to the "seriousness of severe liver injury."

The FDA also recommended that healthcare professionals should weigh the benefits of weight-loss against the potential risks associated with orlistat before prescribing or recommending these drugs for patients.

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