Prexige to be withdrawn in Canada

October 4, 2007, Health Canada the equivalent of the Saudi Food and Drug Authority (SFDA), announced 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, and used 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.

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.

On 29 August 2007, SFDA announced that this product (200mg and 400mg tablets) was withdrawn in New Zealand

The sale of this product in the Kingdom of Saudi Arabia is not authorized, is not legally available on the Saudi market. But it is possible that this product is available to some frequent international travelers, internet buyers and through special purchase requests made by Saudi residents. Accordingly, the Saudi Food and Drug Authority encourages consumers to avoid using this medication (product).

Report Adverse Drug Reactions to the Saudi FDA

The public and health professionals are encouraged to report adverse drug reactions of any drug to the National Pharmacovigilance center on the internet at: