Healthy Skepticism Library item: 11803

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Publication type: Journal Article

Burton B.
COX 2 inhibitor rejected in North America but retained in Europe
BMJ 2007 Oct 20; 335:(7624):791
http://www.bmj.com/cgi/content/short/335/7624/791-a?etoc

Abstract:

Doctors in the UK will continue to be able to prescribe the cyclo-oxygenase-2 (COX 2) inhibitor Prexige (lumiracoxib) even though it has been withdrawn from the market in Canada and the US Food and Drug Administration (FDA) has refused to approve it.

Health Canada, the government agency with responsibility for drug registration, reviewed the safety of the 100 mg dose of lumiracoxib, following the withdrawal of the 100, 200, and 400 mg doses of lumiracoxib from the Australian market in August (BMJ 2007;335:363 doi:10.1136/bmj.39311.635822.DB). On 4 October the department announced that it had withdrawn marketing approval of the 100 mg dose of lumiracoxib due to the risk of “serious liver-related adverse events” including hepatitis. The department, which had first approved the drug in November 2006, reported that two cases of liver damage in Canada had been associated with the drug and concluded that “the risk of serious liver-related . . .