According to the Associated Press, the Food and Drug Administration is investigating reports of liver damage in patients taking alli, the only nonprescription weight loss drug approved by the agency and Xenical, the prescription version of the drug. It is not known yet whether this will have any bearing on GlaxoSmith's petition to FDA requesting that all to weight loss dietary supplements be classified as drugs that was submitted last spring for consideration.
On Monday, regulators made public that they have received more than 30 reports of liver damage in patients taking alli and Xenical, the prescription version of the drug. Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat (the active ingredient in alli and Xenical) 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.
Even with the adverse reports, FDA says it has not found a direct relationship between the drugs and liver problems, and therefore recommended that patients continue to take the drugs as advised from their physicians, according to the Associated Press. "Consumers should consult their health care professional if they are experiencing symptoms," FDA said on its Website, and warned of signs of liver damage including fatigue, fever, nausea and vomiting.
FDA urges both healthcare professionals and consumers to report side effects from the use of orlistat (Alli and Xenical) to FDA's MedWatch Adverse Event Reporting program.
British pharmaceutical GlaxoSmithKline PLC is the maker of Alli, and the Swiss firm Roche makes Xenical. In a statement to the Associated Press, GlaxoSmithKline said there was no evidence that the drug causes liver injury, specifically because the drug acts on the intestinal tract, adding that the cause could be from other problems such as obesity.
Since FDA approved Xenical in 1999 and alli in 2007, the dietary supplement company has pondered as a whole whether companies like GlaxoSmithKline win their petition for all weight loss dietary supplement products to be classified as drugs. The Natural Products Association responded in May 2009 by saying the move was "nothing more than an attempt by the makers of alli™, the first over-the-counter weight loss drug, to quash competition from the supplement weight loss industry."
The concern was that GlaxoSmith's bountiful recourses for legal and political wrangling would outnumber the supplements industry. Time will tell whether the report shaves away their resolve and their resources. Shares of London-based Glaxo fell 59 cents Monday to close at $39.44.