Special Report: Pfizer releases data raising question about cardiac safety of celecoxib (Celebrex)

In a press release by Pfizer today (12/17/04) the Data Safety Monitoring Board reported that in a National Cancer Institute (National Institutes of Health) Adenoma Prevention trial with Celecoxib (Celebrex), "patients taking 400 and 800mg of Celebrex daily had an approximately 2.5 fold increase in their risk of experiencing a major fatal or non-fatal cardiovascular event compared to those patients taking placebo."

Although we have not had the opportunity to see the actual data, we are concerned that this side effect occurred at a dose of Celebrex (400mg/day) that is taken by many patients with arthritis. Until the data can be fully reviewed, we are recommending that patients who absolutely need this drug for control of arthritis contact their physicians to discuss the risk/benefit implications of continuing treatment with Celebrex. Patients who are concerned or who are uncertain of the benefit they are getting from Celebrex should discuss switching to another non-steroidal anti-inflammatory medication (NSAID) with their physicians. When we have the opportunity to fully evaluate the data from this trial we will provide additional comments and advise on this website.

For more information, please read the press release from Pfizer.

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posted 12/17/2004