Australian Drug Regulator Cancels Registration of Prexige

Australia’s drug regulator, the Therapeutic Goods Administration (TGA) has cancelled the registration of the osteoarthritis drug Prexige because of serious liver side effects associated with the use of the drug.

According to the TGA, Novartis’ Prexige (lumiracoxib)  is a Cox 2 inhibitor belonging to the group of medicines known as non-steroidal anti-inflammatory drugs.

Prexige was first approved in Australia in July 2004, but has only recently become widely used since being listed on the Pharmaceutical Benefits Scheme in 2006, the agency added.

As of Aug. 10, According to the Rohan Hammett, TGA’s principal medical adviser, the agency had received eight reports of serious adverse reactions to the drug, including two deaths and two liver transplants.

Approximately 60,000 Australians take Prexige for symptomatic relief of osteoarthritis, acute pain — including postoperative pain and pain related to dental procedures — and pain due to primary dysmenorrhoea, the agency added.