News Update: FDA probes liver damage with weight loss pill Alli
WASHINGTON DC: Regulators report they have received more than 30 complaints of liver damage in patients taking Alli and Xenical, the prescription version of the Alli diet pill. Alli is the non-prescription version of Xencial with a lower dose vs. its prescription version. These complaints were submitted between 1999 and October 2008 and included 27 hospitalized patients, and six who suffered liver failure. The FDA said on its Web site that signs of liver damage include fatigue, fever, nausea and vomiting. The FDA said it’s reviewing additional details about the suspected cases of liver injury.
The Food and Drug Administration is continuing its investigation of liver damage in patients taking Alli, the exclusive nonprescription weight loss drug approved by the agency. Both Alli and Xenical are marketed by British drugmaker GlaxoSmithKline PLC, though Xenical is manufactured by Swiss firm Roche.
The FDA first approved Xenical in 1999 and alli in 2007. The prescription pill is twice as potent as alli, which can be bought over the counter. Glaxo reported $123 million in sales for alli last year, while Roche posted $472 million in revenue for Xenical. In general, the FDA has started notifying the public earlier about possible safety issues with drugs, after coming under fire for acting too slowly on problems with blockbuster treatments like Merck’s painkiller Vioxx.