title: Severe acute liver injury associated with lumiracoxib.
abstract: OBJECTIVE
  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 It was withdrawn from the Australian market in August 2007, because of an association with severe liver injury.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 injury in patients taking lumiracoxib
  
  
  METHODS
  Three patients admitted to our hospital with severe liver injury and taking lumiracoxib are 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 lumiracoxib 200-400 mg daily, typically for a few months, for osteoarthritis.
  
  
  CONCLUSIONS
  Lumiracoxib can be associated with severe liver injury. The presence of a variety of positive auto-antibodies suggests an altered immune response may be contributory.
authors.affiliation: Department of Clinical Pharmacology, Princess Alexandra Hospital, Brisbane, Queensland, Australia. peter_pillans@health.qld.gov.au
authors.forename: Peter I
authors.initials: PI
authors.lastname: Pillans
authors.forename: Razvan A
authors.initials: RA
authors.lastname: Ghiculescu
authors.forename: Guy
authors.initials: G
authors.lastname: Lampe
authors.forename: Robert
authors.initials: R
authors.lastname: Wilson
authors.forename: Richard
authors.initials: R
authors.lastname: Wong
authors.forename: Graeme A
authors.initials: GA
authors.lastname: Macdonald
mesh_terms: D000208:Acute Disease; D001323:Autoantibodies / Q000032:analysis; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology* / Q000276:immunology / Q000473:pathology; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D004008:Diclofenac / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D017809:Fatal Outcome; D005260:Female; D006801:Humans; D016031:Liver Transplantation; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy
chemical_list: D001323:Autoantibodies; D052246:Cyclooxygenase 2 Inhibitors; D004008:Diclofenac; C473384:lumiracoxib