Healthy Skepticism Library item: 11664

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Publication type: Journal Article

Burton B.
Australian drugs regulator cancels registration of COX 2 inhibitor
BMJ 2007 Aug 25; 335:(7616):363
http://www.bmj.com/cgi/content/short/335/7616/363-a?etoc

Abstract:

The Australian drug regulator has cancelled the registration of Novartis’s osteoarthritis drug Prexige (lumiracoxib), a cyclo-oxygenase-2 (COX 2) inhibitor, after eight cases of serious liver side effects, including two deaths, with another two patients needing liver transplants.

The Therapeutic Goods Administration approved the 200 mg and 400 mg a day doses for the treatment of osteoarthritis in July 2004 based on the clinical trial data available at the time. Although the drug was on sale from November 2005, it was only after the 200 mg dose was added to the government subsidised Pharmaceutical Benefits Scheme in August 2006 that sales jumped. At that time the National Prescribing Service, an independent reviewer of drug performance, cautioned that the long term safety of lumiracoxib was unknown and that paracetamol should be used as preferred treatment.

Novartis Australia’s corporate affairs director, Rebecca Fisher-Pollard, said that the drug was registered in Australia at the . . .