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FDA Adds Liver Injury Warnings to Drugs Alli and Xenical

Posted on Jun 03, 2010

After a study of the drugs Alli and Xenical the U.S. Food and Drug Administration has added new warnings about their use.  While Alli is available over the counter and Xenical can only be obtained with a prescription both drugs contain the same active ingredient, orlistat. 

Both Alli and Xenical have been shown to increase the risk of severe liver injury.  Though the FDA has found that "a cause and effect relationship of severe liver injury with orlistat use has not been established" they have asked the makers of the drug to include the following warnings on all packaging:

  • Be aware that cases of severe liver injury have been reported rarely in people taking Xenical and Alli.
  • Contact your healthcare professional if you develop itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.
  • Talk to your healthcare professional about any concerns you have with these medications.
  • Report any side effects with Xenical or Alli to FDA's MedWatch program.


The new warning labels on these drugs do indicate that the FDA is aware of the potential dangers of the drugs Alli and Xenical.  If you believe that one of these products has caused you or a family member harm please contact your Wisconsin, Illinois and Iowa pharmaceutical class action attorneys at Hupy & Abraham today for your free consultation.  While one voice may be ignored by big pharma together we can send a message, "We have been harmed by your drugs and we will be heard."

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