FDA: Weight Loss Pill Linked to Liver Injury

The maker of the weight loss drug Alli, has been directed to change the label for the drug about rare but severe liver injury. The weight loss drug is known generically as Orlistat and it has the potential to cause severe liver damage in rare cases among patients taking the drug.

Orlistat is sold as a prescription drug, Xenical, in 120 mg capsules. Over-the-counter (OTC) it is sold as Alli in 60 mg strength. The Food and Drug Administration (FDA) has now identified 13 victims who developed severe liver injury after taking Orlistat. The review covered a ten-year period.

The FDA reminds us that about 40 million people have taken this drug, both the prescription and OTC version. Among the injuries reported – one resulted from taking Alli in the U.S., and a dozen adverse event reports came from foreign countries and involved taking the prescription drug Xenical.

Patients have been warned that if they experience yellow eyes, dark urine, yellow and itching skin, light colored stools, and loss of appetite, these could all be symptoms of liver dysfunction. Patients should seek the advice of a doctor.

Alli is marketed by GlaxoSmithKline PLC at a lower dose (60 mg), while Xenical, the prescription version is made by Roche Holding AG (120 mg).

The FDA has not confirmed that a cause and effect relationship exists between Xenical or Alli and liver damage.

Xenical was approved in 1999 and became the first nonprescription drug to treat obesity in America. Four years ago, the consumer group, Public Citizen, petitioned the FDA to remove the drug from the market because the obesity treatment increased ACF (aberrant crypt foci) which is believed to be a precursor to colon cancer. With at least 30 percent of the U.S. population considered obese and not likely to exercise or diet, a pill sounds like a good idea. But not this pill. If you have been injured by Alli or Orlistat, contact a Florida defective drug attorney familiar with the latest on this controversial drug to investigate whether you have a defective product action against the drug makers.