Health Canada reviews Prexige safety

Health Canada is currently requesting and reviewing new safety information regarding serious liver adverse events in patients using Swiss drug major Novartis' Prexige (lumiracoxib), a COX-2 inhibitor non-steroidal anti-inflammatory drug used in the treatment of osteoarthritis in adults.

The Therapeutic Goods Administration, the federal regulatory authority in Australia, recently withdrew market authorization for Prexige due to eight reports of serious liver adverse events linked to the drug, including two deaths and two liver transplants (Marketletter August 13). These adverse events were primarily with use of 200mg and 400mg daily doses.

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 OA in adults. The current label indicates that this drug should not be used in patients with severe liver impairment or active liver disease. The Canadian maximum daily dose recommended is 100mg, whereas, in Australia, the maximum dose recommended ranged from 100mg to 400mg daily. Due to safety concerns associated with all COX-2 inhibitors, there is a comprehensive post-market program for monitoring the safe use of Prexige, noted the Canadian regulator.