Alli and Xenical (Orlistat) Could Cause Severe Liver Injury: FDA Warns of Dangers of Weight Loss Drug

Yet another weight loss drug has been accused of posing a safety risk due to its potential causing of liver damage or failure. Yesterday the U.S. Food and Drug Administration (FDA) completed its safety review of the the weight loss drug Orlistat, which has been marketed under the names of Alli and Xenical, in connection with reports of severe liver injury. Alli is manufactured by GlaxoSmithKline (GSK), while Xenical is manufactured by Hoffmann-La Roche (Roche).

These reports of potential liver damage due to a weight loss drug come on the heels of similar reports of liver injury associated with Hydroxycut, which led to a massive recall of the weight loss supplement.

After undergoing an investigation into the safety of Xenical and Alli, the FDA found that Alli and Xenical could in fact cause liver damage in rare cases and therefore has approved the weight loss drugs to stay on the market as long as their labels are changed to include warnings of potential liver damage.


While Alli’s website provides information about the FDA’s findings regarding the drug’s saftey risk and the change to the warning labels, as of this morning Roche’s Xenical website does not have any mention of Xenical’s saftey risk or FDA findings. Even though the Roche website does have a “Safety Information” page specifically for Xenical, it does not contain any reports of any serious liver injury after taking Xenical.

The new FDA-approved warnings are to include some information regarding the 12 reported cases of liver damage following the use of Alli and/or Xenical. Only one of these 12 liver injuries occurred within the U.S. and was due to the ingestion of Alli. While Xenical is a prescription weight loss drug, Alli can be bought over-the-counter at many drug stores and health product distributors.

People taking Xenical and Alli should be aware that the FDA has found both weight loss supplements to contain about 120 milligrams of orlistat, the active ingredient in both drugs and what has been linked to the liver injury cases. Consumers of Xenical and Alli should keep a lookout for the early signs of liver injury and/or jaundice, which include yellow eyes and skin, loss of appettite, dark urine, and itching.

If you think that you have been injured by using either Xenical or Alli, please contact Kreisman Law Offices. With over 30 years of experience litigating consumer cases against pharmaceutical companies in Illinois and all over the country, Kreisman Law Offices can help you obtain justice.

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