Alli And Xenical
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IMAGE SOURCE: Alli Web site /image of Alli
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The Food and Drug Administration (FDA) is investigating whether the over-the-counter (OTC) weight loss drug, orlistat (as Alli), and by prescription, (as Xenical) can cause liver damage.
The drugs might not even work well enough to warrant such a potential risk, reports the Atlanta Journal-Constitution.
Weight loss from Alli is believed to be a modest five kilograms (about 11 pounds).
Dr. Timothy Pfanner at Texas A & M says “It’s not a really effective drug. The benefit is not so great to begin with,” he said. Many obese people already have liver problems, which Dr. Pfanner believe the drug may complicate.
Taken over-the-counter, there is no way to evaluate the number of people suffering complications.
In April, the FDA looked at the issue of safety and the consumer group, Public Citizen petitioned the FDA in 2006 to remove Xenical from the market because of its link to the risk of aberrant crypt foci, a possible precursor to colon cancer.
Orlistat is approved in about 100 countries with an OTC form available in the European Union.
The FDA stressed Monday there is no reason for patients to stop taking the drug.
Symptoms of liver damage might include weakness, fatigue, fever, jaundice, or brown urine. A loss of appetite, nausea and vomiting could also indicate trouble.
Between 1999 and 2008, there have been 32 reports of serious liver injury, including six cases of liver failure.
GlaxoSmithKline makes Alli while Roche Laboratories markets the prescription strength drug, Xenical.
A GSK spokeswoman says there is no evidence Alli causes liver damage. "Alli is a ‘non-systemically’ acting medicine – it is minimally absorbed in the blood and works locally in the gastro-intestinal tract," wrote Deborah G. Bolding in an e-mail reply to Triangle Business Journal.
The drug has been on the market for ten years. It was first used as a prescription, but in 2007 became the first OTC drug to be used to treat obesity in the U.S. #