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Reuters Health Information (2007-10-04): Canada pulls Prexige on hepatitis fears

Regulatory

Canada pulls Prexige on hepatitis fears

Last Updated: 2007-10-04 15:20:03 -0400 (Reuters Health)

TORONTO (Reuters) - Canada said on Thursday it has stopped the sale of Novartis Pharmaceuticals Canada Inc's anti-inflammatory drug Prexige (lumiracoxib) and will cancel its market authorization due to the risk of serious liver-related effects, mainly hepatitis.

It said there have been four cases internationally, including two cases in Canada, of hepatitis associated with the 100-mg dose.

The decision to withdraw the drug came following a review of information from Novartis, which the government's health department, Health Canada, requested after Australia pulled Prexige from its market in August after it was linked to liver diseases at doses of 200 mg and 400 mg.

Prexige, a COX-2 selective inhibitor non-steroidal anti-inflammatory drug, has been marketed in Canada since November 2006 for the treatment of osteoarthritis in adults at a maximum daily dose of 100 mg.

Health Canada recommended that patients using the drug contact their doctors for alternative treatments.

Late last month, the U.S. Food and Drug Administration rejected Prexige, giving the drug a "non-approvable letter." At the time, Novartis said it would continue talks with the FDA. The drug is still available in Europe.

 
 
 
 
                 
 
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