Health Canada Pulls ‘Prexige’ Off Market, Citing Liver Damage Risk
Health Canada is blocking the sale of the arthritis drug Prexige in Canada, owing to the potential for grave liver problems in people consuming the drug.
The group is also terminating the market authorization of the drug.
Prexige was sanctioned for sale in Canada in November 2006. It was prescribed for treating the knee osteoarthritis symptoms, at a highest daily dosage of 100 milligrams. In July, 2007, its authorization was extended to comprise cure of general osteoarthritis in grownups.
Health authorities in Australia has also hit the drug from its market in August, 2007, after getting reports of severe liver problems when people took the drug in 200 milligram and 400 mg quantities on a daily basis.
Two cases of grave undesirable effects to the liver have been reported in Canada.
Health Canada has launched an appraisal of the safety information for the drug soon after. The department stated that at the time that Prexige should be used at the lowest effective dose for the shortest possible duration.
In its message, the agency said, “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.”
There have been four cases of liver problems worldwide, comprising the two Canadian cases, linked with the 100 mg dosage.