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November 21, 2001

Reporting of 6-Month vs 12-Month Data in a Clinical Trial of Celecoxib

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor


Copyright 2001 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2001

JAMA. 2001;286(19):2398-2400. doi:10.1001/jama.286.19.2398

To the Editor: Cyclooxygenase-2 inhibitors such as celecoxib (Celebrex) are generally presumed to have a lower risk of causing complicated peptic ulcers and other serious GI toxicity than other nonsteroidal anti-inflammatory drugs (NSAIDs).

The full data from the CLASS trial,1 which are publicly available on the FDA Web site,2 call these beliefs into question.3 The FDA found that "For upper GI safety, and also for global safety, there does not appear to be any meaningful advantage for Celebrex."4

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