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Osteoarthritis drug Prexige under review by Health Canada

Thursday, August 16, 2007 | 12:52 PM ET

Health Canada is reviewing the safety of the anti-inflammatory Prexige (lumiracoxib) following reports of serious liver adverse events in some patients in Australia.

Prexige, made by Novartis Pharmaceuticals Canada Inc., is a Cox-2 inhibitor, non-steroidal drug used to treat adult osteoarthritis.

Australia's federal regulatory authority, the Therapeutic Goods Administration, recently withdrew market authorization for Prexige due to eight reports of serious liver adverse events linked to the drug.

These included including two deaths and two liver transplants in Australia, primarily involving use of 200-mg and 400-mg doses daily.

In Canada, Prexige was authorized for sale in November 2006 for acute and chronic treatment of the signs and symptoms of knee osteoarthritis in adults, and in July 2007 for general osteoarthritis in adults.

The current label indicates the drug should not be used in patients with severe liver impairment or active liver disease.

The Canadian maximum daily dose recommended is 100 mg; in Australia, the maximum daily dose recommended ranged from 100 mg to 400 mg daily.

Once Health Canada has reviewed the available data, new information, including any resulting recommendations, will be made public to Canadians and health-care professionals.

Health Canada advises patients that Prexige should be limited to the lowest effective dose for the shortest possible duration of treatment.

They should consult with their doctors before making any change to their medication, or if they have any questions or concerns.

Advisory notice

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