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Australian drugs regulator cancels registration of COX 2 inhibitor

BMJ 2007; 335 doi: http://dx.doi.org/10.1136/bmj.39311.635822.DB (Published 23 August 2007) Cite this as: BMJ 2007;335:363
  1. Bob Burton
  1. Canberra

    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 …

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