Health Canada pulls market approval for drug Prexige, citing liver problems

From the Canadian Press:
Health Canada has ordered the anti-inflammatory drug Prexige off the market, citing the potential for severe liver-related side-effects.

The department said it was stopping sales and would cancel market authorization for lumiracoxib, which is sold as Prexige by Novartis Pharmaceuticals Canada Inc.

People taking the drug are being instructed to talk with their doctors about finding an alternate pain relief therapy.

"Given the availability of alternative treatment not known to present a similar level of risk, Health Canada decided that the safest option was to withdraw the drug from the market," department spokesperson Alastair Sinclair said in e-mailed responses to questions. ...more

Health Canada reviews osteoarthritis drug after Australia concerns

From the Globe and Mail:
Health Canada says it is reviewing safety information for the drug Prexige (lumiracoxib) after Australian health authorities withdrew the drug from that market due to reports of serious liver problems, including two deaths, in eight people who had taken the drug.

Health Canada says it has asked for information about adverse events involving the liver from the drug's manufacturer, Novartis, and will update recommendations to the public and health care professionals if necessary.

Prexige is a member of the troubled cox-2 inhibitor class of drugs, a class which includes the now withdrawn drug Vioxx. Prexige is used for treatment of osteoarthritis in adults.

Australia's Therapeutic Goods Administration recently withdrew market authorization for Prexige due to eight reports of serious liver adverse events linked to the drug in that country, including two deaths and two liver transplants. ...more