Prexige (lumiracoxib), a COX-2 inhibitor used to treat osteoarthritis and acute pain, has been withdrawn from the market in Australia. In compliance with a decision from the Therapeutic Goods Administration, Novartis Pharmaceuticals Australia withdrew all doses of the drug on August 11th. The decision came after a number of serious liver side effects were reported in Australian patients taking Prexige, including two deaths and two liver transplants. Serious liver side effects have rarely been reported for other COX-2 inhibitors or traditional NSAIDs. Prexige was first marketed in Australia in November 2005. More information is offered by Novartis Australia.
Following the news of the Prexige withdrawal in Australia, Health Canada initiated a review of the safety of Prexige. In Canada, Prexige was marketed in November 2006 for acute and chronic treatment of the signs and symptoms of knee osteoarthritis in adults, and in July 2007 for general osteoarthritis in adults. The label warns that Prexige should not be used by patients with severe liver impairment or active liver disease. In Canada, the maximum daily dose of Prexige is 100 mg. while in Australia the maximum recommended daily dose ranged from 100 - 400 mg.
New Zealand was the third country to react to the news from Australia. On August 21, New Zealand health officials banned the use of 200 mg. and 400 mg. Prexige. The 100 mg. Prexige stayed on the market in New Zealand but officials said use would be closely monitored. Not many New Zealanders had been taking the higher dose.
In the United States, Prexige has yet to be FDA-approved. Some sources expected it to be approved in 2007 while other sources said the drug was facing an uphill battle.
UPDATE 10/3/2007: FDA Deems Arthritis Medicine Prexige "Not Approvable"
UPDATE 10/4/1007: Health Canada Stops Sales of Prexige
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