Risk of acute hepatitis increased with NSAIDs, mainly celecoxib

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Risk of acute hepatitis increased with NSAIDs, mainly celecoxib An increased risk of hospitalisation with acute hepatitis was observed among patients previously exposed to nimesulide, diclofenac, ibuprofen, and other hepatotoxic NSAIDs, particularly celecoxib, in a study conducted in Taiwan. Data for 4591 hospitalised patients with a major diagnosis of acute or subacute necrosis of the liver or toxic hepatitis were extracted from Taiwan’s National Health Insurance (NHI) database during the period April 2001–December 2004. Using a case-crossover design, the researchers found that 35, 19, and 30 patients had been prescribed celecoxib, rofecoxib, and nimesulide, respectively, within the 28-day risk period prior to hospitalisation. The ORs for hepatitis with celecoxib, nimesulide, diclofenac, ibuprofen, and other hepatotoxic NSAIDs were "significantly increased", say the researchers. Moreover, compared with the adjusted ORs in bidirectional analyses for other hepatotoxic NSAIDs (2.13; 95% CI 2.00, 2.28), the OR for celecoxib (1.92, 1.38, 2.69) was "similar" during the 28 days by unidirectional case-crossover design, comment the researchers. There appeared to be "no significant dose-response relationship for celecoxib" when daily doses were stratified into < or > 200 mg/day, or cumulative doses into < or > 2000 mg. "Further mechanistic research is warranted" regarding celecoxib’s hepatotoxicity, state the researchers. Lee CH, et al. Increased risk of hospitalization for acute hepatitis in patients with previous exposure to NSAIDs. Pharmacoepidemiology and Drug Safety 19: 708-714, No. 7, 13 May 2010. Available from: URL: http://dx.doi.org/10.1002/ 803030564 pds.1966

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Reactions 7 Aug 2010 No. 1313