The Food and Drug Administration is toughening up the label on the popular weight-loss drug, Alli, also sold by prescription as Xenical. The new label will include a warning about the possibility of liver injury. Xenical is made by Roche Holding AG while Alli is an over-the-counter lower-dose version of the same drug marketed by GlaxoSmithKline PLC (GSK). The active ingredient in both drugs is orlistat.
The FDA has received 12 reports of liver injury associated with Xenical from outside the U.S. and one report associated with Alli. Among those reports, two people died and three needed a liver transplant. Experts say that is a small number considering that an estimated 40 million people worldwide have used Xenical or Alli.
Roche said the company would continue to monitor Xenical’s safety profile and share that information with health regulators.
GSK says the updated label on Alli will tell consumers to stop using the drug and seek medical help if they “develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat.” Combining orlistat with other drugs may also lead to serious liver injury.
The FDA says that at this time, a cause-and-effect relationship has not been established. However, because of the seriousness of the liver injuries, the warning is being added to educate the public about the signs and symptoms of liver injury.
