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Canadian Regulator Reviewing Prexige Safety

August 24, 2007

Health Canada announced it is reviewing new safety information on serious liver adverse events in patients using Novartis’ Cox-2 inhibitor Prexige, a treatment for osteoarthritis.

Prexige was first approved in November 2006 for treating osteoarthritis of the knee. Health Canada then approved the drug last month for general osteoarthritis. The label indicates that this drug should not be used in patients with severe liver impairment or active liver disease, the agency said.

The maximum recommended daily dose in Canada is 100 mg, the agency said. Health Canada recommends that treatment with Prexige be limited to the lowest effective dose for the shortest possible duration.

Once the agency has reviewed new data, the information will be made public. The agency also noted that due to safety concerns associated with all Cox-2 inhibitor drugs, there is a comprehensive postmarket safety-monitoring program in place for Prexige.