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Health Canada Removes Cox-2 Drug Prexige From the Market Over Liver Problems

Posted on: Thursday, 4 October 2007, 15:00 CDT

By Helen Branswell, Medical Reporter, THE CANADIAN PRESS

TORONTO - Health Canada has ordered the anti-inflammatory drug Prexige off the market, citing the potential for serious liver-related adverse events.

In a release, the department said it was stopping sales and would cancel market authorization for lumiracoxib, which is sold by Novartis Pharmaceuticals Canada Inc. as Prexige. In a statement posted on its website, the company said it will comply with Health Canada's request.

"Patients in Canada who are taking Prexige should stop taking this treatment immediately and consult their doctor to seek advice on other treatment options," Novartis said in its release.

Prexige was approved in Canada in November 2006 as an acute and chronic treatment of the signs and symptoms of knee osteoarthritis in adults. In July of this year its approval was widened to include treatment of general osteoarthritis in adults.

The development is the latest blow for the troubled class of drugs known as cox-2 inhibitors, once a giant in the world of pharmaceutical sales.

In September 2004 the most popular drug in the class, Vioxx, was withdrawn from worldwide markets over evidence it elevated the risk of heart attack and stroke in users. Later Health Canada forced another cox-2 inhibitor, Bextra, from the market over concerns it raised the risk of a rare but life-threatening skin condition.

With the removal of Prexige, only one of the formerly widely used painkillers remains on the Canadian market. That is Celebrex, made by Pfizer.

Prexige, which was approved for sale in Canada less than a year ago, has been linked to rare but serious liver problems in some users. Two such cases have been reported in Canada.

Australia's Therapeutic Goods Administration removed the drug from the market there in August after eight reports of side-effects involving serious liver problems when people took Prexige in 200 milligram and 400 mg doses daily. Two of the people involved died and two required liver transplants.

While Australian drug authorities allowed the drug to be marketed with a daily dose set at between 100 mg to 400 mg daily, the Canadian maximum daily dose was set from the start at 100 mg.

Following the Australian decision, Health Canada undertook a review of the drug's safety data. In its statement Thursday the drug regulator said it had reached the conclusion the risk of serious liver-related adverse events cannot be safely managed at the 100 mg daily dose.

Source: Canadian Press

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