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BMJ. 2007 October 20; 335(7624): 791.
PMCID: PMC2034708

COX 2 inhibitor rejected in North America but retained in Europe

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continue to be able to prescribe the cyclo-oxygenase-2 (COX 2) inhibitor Prexige (lumiracoxib) even though it has been withdrawn from the market in Canada and the US Food and Drug Administration (FDA) has refused to approve it.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 On 4 October the department announced that it had withdrawn marketing approval of the 100 mg dose of lumiracoxib due to the risk of “serious liver-related adverse events” including hepatitis.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 adverse events with Prexige cannot be safely and effectively managed at the 100 mg daily dose.”

While both Canada and Australia have withdrawn marketing approval for the drug, the 100 mg daily dose remains available in more than 50 countries, including the UK and other countries in the European Union and Latin America. Its manufacturer, Novartis, held high hopes for the drug, which earned $47m (£23m; €33m) for the company in 2006, a 488% increase on the previous year's sales. The 200 mg and 400 mg daily dose versions remain on the market in about 20 countries, including South Africa and countries in Latin America.

On 27 September Novartis announced that it had received a letter from the FDA stating that the 100 mg dose of lumiracoxib was “not approvable.” Novartis claimed that the agency “remained open to exploring the use of this medicine in patients where Prexige would provide an acceptable benefit-to-risk balance,” but Novartis spokesman John Gilardi declined to provide a copy of the administration's letter.

Following withdrawal of lumiracoxib in Australia, the UK Medicines and Healthcare Products Regulatory Agency said that patients with current liver disease should not be prescribed the drug and that those who are suitable for treatment with lumiracoxib should have their liver function monitored.

The agency also instigated a review on the safety of the 100 mg daily dose of lumiracoxib, but it concluded that no further restrictions on its use were being imposed, said a spokesman for the agency. “Most concern over liver toxicity relates to doses higher than the 100 mg daily dose . . . No further restrictions are considered necessary on the basis of current evidence,” he said.

For Novartis, the withdrawal of UK marketing approval would have major ramifications, as the drug was first approved in the UK and then gained European approval under the EU's mutual recognition procedure.

In August, the New Zealand Medicines and Medical Devices Safety Authority withdrew approval for the 200 mg and 400 mg doses of lumiracoxib but not for the 100 mg daily dose.


Articles from The BMJ are provided here courtesy of BMJ Publishing Group