Alli and Xenical: Risk for Liver Damage?

The FDA is investigating whether the weight-loss drug orlical may be causing liver damage. The only medication approved by the FDA for weight loss, orlical is sold as the over-the-counter drug Alli and as the prescription drug Xenical. An article from the Associated Press says that the agency announced yesterday that it had received 30 reports of patients with liver damage from taking Alli and Xenical.

According to an FDA statement (link below), “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. Thirty of the 32 reports occurred outside the United States. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalization was reported in 27 of the 32 cases.” It says that it is continuing to analyze the data.

The FDA has said that it hasn’t found a definitive association between orlistat and liver injury, and recommends that users of the drug keep using it. The agency advises patients to consult their doctor if they experience any of the possible signs of liver injury or damage, such as:


  • weakness or fatigue
  • fever
  • jaundice
  • brown urine
  • nausea or vomiting
  • abdominal pain

You can read the FDA’s statement about Xenical, Alli, and orlistat here. The FDA approved Xenical in 1999; Alli gained approval in 2007. Xenical contains 120mg of orlistat, while Alli has 60mg.

You can find out more about Xenical at the Drugs.com profile page or at the manufacturer’s Web site, www.xenical.com.

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