Anti-inflammatory drug Prexige is called off the market Thursday due to the potential risk of causing serious liver-related adverse events.
Health Canada said sales and market authorization of the drug will be stopped for lumiracoxib, which is sold by Novartis Pharmaceuticals Canada Inc. as Prexige.
Prexige treats acute and chronic 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.
Prexige, which was approved for sale in Canada less than a year ago, has recently been linked to rare but serious liver problems in some users. Two such cases have been reported in Canada.
Australia's drug regulatory agency, the Therapeutic Goods Administration, removed Prexige from its market 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.
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, which Canada had set as the drug's daily maximum dose.
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