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New Zealand Bans Larger Doses of Arthritis Drug Prexige, Cites Liver Damage Risk (New Zealand)

This article was originally published in PharmAsia News

Executive Summary

New Zealand's medicine watchdog Medsafe has imposed a ban on the supply of high-level doses of the pain relief drug Prexige, which has been linked to an increased risk of liver damage. The government agency has ordered the withdrawal of 200 milligram and 400 milligram doses of Prexige tablets, produced by Swiss pharmaceutical company Novartis AG. The agency says that the 100 milligram dose tablets would stay on the market, though their use would be closely monitored. The anti-inflammatory drug was withdrawn in Australia after it was blamed for the deaths of two people and for triggering liver failure that required two others to have transplants. Medsafe spokesman Stewart Jessamine says its medicines adverse reactions committee discussed the overall risks and benefits of the use of Prexige with regulators in Australia, Singapore and Britain. It "concluded that the data for higher doses of lumiracoxib, the active ingredient in Prexige, support an association with liver damage that was greater than that seen for other anti-inflammatory medicines," he says. "This increased risk of liver damage for Prexige outweighs any of the potential benefits claimed for the 200 milligram and 400 milligram dose," Jessamine adds. Sheldon Jones, a spokesman for Novartis in Switzerland, said, "We're continuing to work with the health authorities about the recent information." (Click here for more - May Require Free Registration
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