Case of cholestatic hepatitis with celecoxib did not fulfil international criteria

BMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7340.789/a (Published 30 March 2002) Cite this as: BMJ 2002;324:789
  1. Felix M Arellano, chief safety officer,
  2. Sean Z Zhao, director pharmacoepidemiology,
  3. Matthew W Reynolds, pharmacoepidemiologist
  1. Pharmacia Corporation, 100 Route 206 North, MS 135, Peapack, NJ 07977, USA

    EDITOR—O'Beirne and Cairns reported a case of cholestatic hepatitis in association with celecoxib.1 This case does not, however, fulfil the accepted international criteria for cholestatic hepatitis as it was not confirmed histologically.2 Biochemical criteria of cholestatic hepatitis require the presence of alkaline phosphatase activity over twice the upper normal limit or a ratio of alkaline phosphatase to alanine aminotransferase activity >2, or both.2 Neither was fulfilled, even when using aspartate aminotransferase as a surrogate of alanine aminotransferase, which was not provided. Moreover, the patient did …

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