In May 1999, the FDA announced a labeling change relative to Celebrex.  The labeling change instituted by Pharmacia reported that patients on warfarin were at an increased risk of  "bleeding complications," such that caution should be used in prescribing Celebrex to them.  This labeling change was not satisfactory to the FDA, however, and on February 1, 2002, the FDA sent Pharmacia a "Warning Letter," requiring the manufacturer to cease certain promotional activities that minimized the risk of excessive bleeding when Celebrex was taken concomitantly with warfarin. 

Additionally, an article published in the August 2001 Journal of the American Medical Association (JAMA) raised concerns over Celebrex's possible impact on cardiovascular health, implicating Celebrex in heart attacks and other heart irregularities.  Although doctors rushed to write rebuttal letters, in September 2001, the American Heart Association, the National Stroke Association and the Arthritis Foundation asked Pharmacia to test whether Celebrex increased the risk of heart attacks and strokes. Pharmacia disputed the findings reported in JAMA and insisted Celebrex is safe.  Although the researchers for the JAMA article analyzed four studies that were not designed to examine the drug’s effects on the heart, until further research is done, patients with heart disease should question their doctor regarding the safety of Celebrex.

Recent Developments: NIH Halts Use of Celebrex in Large Cancer Prevention Trial

On December 17th, 2004 the National Institutes of Health (NIH) announced that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute (NCI). The study, called the Adenoma Prevention with Celecoxib (APC) trial, was stopped because analysis by an independent Data Safety and Monitoring Board (DSMB) showed a 2.5-fold increased risk of major fatal and non-fatal cardiovascular events for participants taking the drug compared to those on a placebo.