The Food and Drug Administration is investigating reports of liver damage in patients taking alli, a nonprescription weight loss drug, which has been approved by the agency. The FDA has received more than 30 reports of serious liver damage in patients taking alli and Xenical, the prescription version of the drug. All but two of the cases involved prescription Xenical and occurred outside the United States. Twenty-seven patients were hospitalized, and six cases resulted in liver failure, according to the FDA. The reports, submitted between 1999 and October 2008, included 27 hospitalized patients, and six who suffered liver failure. The drug is known generically as Orlistat.
Both Alli and Xenical are marketed by British drug maker GlaxoSmithKline PLC, (GSK) but Xenical is manufactured by Swiss firm Roche. The FDA says it has not established a direct relationship between the weight loss treatments and liver injury, and advised patients to continue using the drugs as directed. The agency says: “Consumers should consult their health care professional if they are experiencing symptoms.”
The FDA said 30 of the liver injury cases occurred outside the United States and involved 120 milligram doses of prescription Xenical. The two U.S. cases were associated with GSK’s nonprescription version of the drug, which is sold under the name Alli, according to the FDA. The nonprescription dose is half of the prescription dose. Roche reported first-half 2009 sales for Xenical of 209 million Swiss francs ($197 million). GSK reported Alli sales of $125 million for the second quarter.
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. GSK reported $123 million in sales for alli last year, while Roche posted $472 million in revenue for Xenical. 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 submitted by manufacturers. 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.
Source: Yahoo News
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