Health Canada (OTTAWA, Canada), the federal department responsible for helping Canadians maintain and improve their health, has advised consumers that it has stopped the sale of the anti-inflammatory drug Prexige® (lumiracoxib) and will cancel the drug's market authorization due to potential serious liver-related adverse events (hepatitis).

Prexige, a COX-2 selective inhibitor nonsteroidal anti-inflammatory drug, had been marketed in Canada since November 2006 for the treatment of the signs and symptoms of knee osteoarthritis (OA) in adults at a maximum daily dose of 100 mg. In July 2007, the drug received Canadian approval for the treatment of OA in all joints.

The decision by Health Canada 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 hepatitis linked to doses of 200 mg and 400 mg daily. As a result, Health Canada has concluded that the risk of hepatitis with Prexige cannot be safely and effectively managed at the 100 mg daily dose.

Internationally, two reported cases of hepatitis have been associated with the 100 mg dose; two Canadian cases of hepatitis have been reported with the higher doses.