Australian Medicines Regulator cancels registration of Lumiracoxib

Australia's medicines Regulator, the Therapeutic Goods Administration (TGA) has cancelled the registration of the osteoarthritis drug, Lumiracoxib because of serious liver side effects associated with the use of the drug.

Lumiracoxib, marketed by Novartis Pharmaceuticals under the brand name of Prexige, is a Cox 2 inhibitor belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDS).

As of 10 August 2007, the TGA had received eight reports of serious liver adverse reactions associated with use of lumiracoxib, including two deaths and two patients requiring liver transplants. All these reports have been received since March 2007, with 6 reports received in the last 6 weeks. The TGA has urgently investigated these reports and as a result has acted to deregister the drug to prevent further cases of liver damage related to lumiracoxib.

Although there is limited data on the natural history of the hepatic side effects of lumiracoxib, the pre-registration clinical trial data suggested that if a patient developed elevated liver function tests while on the drug, they were likely to normalise their biochemistry when the lumiracoxib was ceased. However, in the 8 serious Australian reports studied, some patients have not improved on cessation of the medicine, due to the severity of the hepatic injury.

The TGA and its expert advisory committee, the Adverse Drug Reactions Advisory Committee (ADRAC), have urgently investigated these reports. ADRAC has today recommended the cancellation of the registration of Lumiracoxib due to the severity of the reported side effects associated with this drug.

The regulator has labelled it as a Class I defect. Class I defects are potentially life-threatening or could cause a serious risk to health.

The TGA has thus advised that all patients cease taking lumiracoxib immediately, and are assessed by their doctor for any clinical or biochemical evidence of liver damage.

Recall letters are expected to be dispatched by the sponsor within the next week.

Source: http://www.tga.gov.au/alerts/prexige.htm

http://www.tga.gov.au/recalls/2007/lumiracoxib.htm

http://www.tga.gov.au/media/2007/070811-lumiracoxib.htm