Canada’s drug regulatory body has ruled that the anti-inflammatory drug Prexige® (lumiracoxib) should be removed from the market due to the potential risk of serious liver damage.
Health Canada said sales and market authorisation for the drug, which is sold by Novartis Pharmaceuticals Canada, will be withdrawn.
Prexige is used to treat acute and chronic signs and symptoms of knee osteoarthritis in adults. In July 2007 its approval in Canada 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, and two such cases have been reported in Canada.
Australia’s Therapeutic Goods Administration removed Prexige from the Australian market in August after eight reports of side-effects involving serious liver problems when people took the drug in 200mg and 400mg daily doses.
Two of those who reported side-effects later died, while another two were forced to have liver transplants.
Following the Australian decision, Health Canada undertook a review of the drug’s safety data.
It concluded that the risk of serious liver-related adverse events could not be safely managed at the 100mg daily dose, which Canada had set as the drug’s daily maximum.
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