Withdrawal of Market Authorization for Prexige

News Release

Advisory
2007-141
October 4, 2007
For immediate release
OTTAWA - Health Canada is advising consumers that it has stopped the sale of the anti-inflammatory drug Prexige (lumiracoxib) in Canada and will cancel the drug's market authorization due to the potential for serious liver-related adverse events.
Prexige, a Cox-2 selective inhibitor non-steroidal anti-inflammatory drug, has been marketed in Canada since November 2006 for the treatment of the signs and symptoms of osteoarthritis in adults at a maximum daily dose of 100 milligrams (mg).
The decision to withdraw market authorization for Prexige follows a review of additional safety information submitted by the drug manufacturer, Novartis Pharmaceuticals Canada Inc. The information was requested after Prexige was removed from the Australian market in August 2007, following reports of serious liver adverse events that were linked to the drug at doses of 200 mg and 400 mg daily. The experience of other international regulators is a potential source of safety signals for new drugs when the Canadian real world safety information is limited.
As a result of its review, Health Canada has concluded that the risk of serious liver-related adverse events with Prexige cannot be safely and effectively managed at the 100 mg daily dose.
Since its approval in Canada, and use in a larger population of patients there have been two Canadian cases of serious liver-related adverse events associated with the use of Prexige. In total, there have been four cases internationally, including the two Canadian cases, of serious liver-related adverse events (hepatitis) reported to be associated with the 100 mg dose.
Patients currently using Prexige should contact their health care provider to discuss appropriate alternative treatment options. Consumers should not dispose of any unused product themselves, but should return the product to their pharmacy in order to ensure appropriate disposal. Any concerns or questions regarding potential reimbursement for patients who were using Prexige should be addressed to the pharmacy location at which Prexige was purchased or to the manufacturer, Novartis Pharmaceuticals Canada Inc.
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Media Enquiries:
Alastair Sinclair
Health Canada
(613) 957-1803
Public Enquiries:
(613) 957-2991
1-866 225-0709

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Withdrawal of Market Authorization for Prexige

News Release

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