Last month the FDA issued a notice that it approved label changes for Roche’s Xenical (orlistat) and GlaxoSmithKline’s (GSK) Alli, the lower dose, over-the-counter version of Xenical. The labels’ changes warn of rare reports of liver injury that have occured in users.
The FDA’s decision to add the warning label came after reviews of clinical trials, data, and postmarketing studies between 1999 and 2009. During this time, 12 users of Xenical reported liver injuries and only one user reported a liver injury while on Alli. Two of the cases resulted in death and three cases required a liver transplant. An established cause and effect has not yet been determined, however, because of the severity of the injuries the FDA was seeing, the agency felt it was necessary to add the warning.
In addition, the FDA recommends that physicians weigh the benefits against the risks when prescribing or recommending either Xenical or Alli.
If you or someone you know has suffered a liver injury from either using Xenical or Alli, please contact Sheller, P.C. at 1-800-883-2299.