(NaturalNews) Canada's government health agency, Health Canada, has announced the withdrawal of market authorization for non-steroidal anti-inflammatory lumiracoxib due to evidence connecting the drug to severe liver damage.
Health Canada requested that Novartis stop selling lumiracoxib, marketed as Prexige, and the company has complied with the request.
Prexige is used primarily to treat osteoarthritis patients, and has been approved for sale in 21 countries. The drug's troubles began in August when the Therapeutic Goods Administration of Australia withdrew its approval for Prexige after reviewing evidence on 8 reports of severe liver damage arising from use of the drug. This included two deaths and two liver transplants. Following Australia's decision, New Zealand also pulled the drug from the market.
According to Health Canada, there have been two confirmed cases of liver-related complications from Prexige in Canada. The agency reviewed additional safety information provided by Novartis, and concluded that "the risk of serious hepatotoxicity associated with the use of Prexige cannot be safely and effectively managed."
Health Canada advised all doctors and pharmacists to discontinue prescribing Prexige, return all samples, and discuss new treatment options with patients currently on the drug. It encouraged patients to return any supplies of the drug to their pharmacists. "In order to avoid contaminating ground or municipal water systems, the product should not be flushed down the toilet or sink," Health Canada said.
In 2003, the U.S. FDA rejected the trade name "Prexige
" for lumiracoxib. The agency has not yet ruled on whether to approve the drug for use and sale in the United States. Likewise, it has not yet been revealed what trade name the drug would use if approved, although "Prexede" has been suggested.
Countries in which Prexige is still approved for use include Argentina, Brazil, Mexico, South Africa and all European Union countries.
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