TORONTO — Canadian Press Last updated on Friday, Apr. 03, 2009 10:28AM EDT
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Prexige is a member of the troubled cox-2 inhibitor class of drugs, a class which includes the now withdrawn drug Vioxx.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.
The adverse events were primarily seen in people who took 200 mg and 400 mg doses daily.
While Australian drug authorities allowed the drug to be marketed with a daily dose set at between 100 mg to 400 mg daily, the Canadian maximum daily dose was set at 100 mg.
In Canada, Prexige was authorized for sale in November 2006 for acute and chronic treatment of the 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.
Its current labelling indicates it should not be used in patients with severe liver impairment or active liver disease.
Health Canada says Prexige should be used at the lowest effective dose for the shortest possible duration of treatment.
Join the Discussion: