Celebrex Dosing in Long-Term Cancer Studies Suspended Due to Increased Cardiovascular Risk in One Study
Friday December 17, 2004
The FDA and Pfizer announced today that the National Cancer Institute has halted an ongoing clinical trial of Celebrex which was investigating use to prevent colon polyps (Adenoma Prevention with Celecoxib trial) due to an increased risk of cardiovascular events in study participants taking Celebrex versus placebo. A similar ongoing study (Prevention of Spontaneous Adenomatopus Polyps) trial has not shown an increased risk. The results are unexpected and inconsistent. The results will be reviewed but Celebrex is not being pulled from the market. Patients taking Celebrex are being advised to discuss continued use with their doctor and weigh individual benefit versus risk. Read the press release from Pfizer and also the statement from the FDA for more details.


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