Australia's TGA withdraws Novartis' coxib OA painkiller Prexige on liver safety fears

Swiss drug major Novartis has complied with a decision by the Australian Therapeutic Goods Administration (TGA) to withdraw Prexige (lumiracoxib), a selective COX-2 inhibitor, used for the treatment of osteoarthritis and acute pain, from the Australian market with immediate effect.

This action was taken because of the TGA's concerns about the liver safety profile of the agent after a number of cases of liver failure were reported in Australian patients, mostly following treatment with higher doses of the agent.

Since its July 2004 approval in Australia, the agency received eight reports of serious liver side effects associated with the use of the drug and in its latest guidance has told all Prexige patients to stop treatment immediately.