Severe acute liver injury associated with lumiracoxib.

Backgound and Aim: Significant elevations in liver transaminases were noted in some patients during pre-marketing clinical trials with lumiracoxib, a selective COX-2 inhibitor. It was withdrawn from the Australian market in August 2007, because of an association with severe liver injury. We describe in detail three cases of severe liver injuryin patients taking lumiracoxibMethods: Three patients admitted to our hospital with severe liver injuryand taking lumiracoxibare described in detail, together with information on a further six cases reported to the Australian Therapeutics Goods Administration (TGA), none of whom had pre-existing liver disease or obvious risk factors for liver disease. Results: Liver histology showed severe hepatic necrosis. One patient required liver transplantation and another died. Autoantibodies were detected in all three patients. As with the other six cases reported to the TGA, all were females who had been taking lumiracoxib200400 mg daily, typically for a few months, for osteoarthritis. Conclusions: Lumiracoxibcan be associated with severe liver injury. The presence of a variety of positive auto-antibodies suggests an altered immune response may be contributory.