(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.

In the APC clinical trial, patients taking 400 mg. of Celebrex twice daily had a 3.4 times greater risk of cardiovascular events compared to placebo. For patients in the trial taking 200 mg. of Celebrex twice daily, the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months. However, a similar ongoing study comparing Celebrex 400 mg. once a day versus placebo, in patients followed for a similar period of time, has not shown increased risk.

Both the manufacturer of Celebrex (Pfizer) and the FDA are currently evaluating the data from these studies.

Also on December 17, the FDA asked Pfizer to voluntarily suspend direct-to-consumer advertising on Celebrex during the time the FDA is obtaining and evaluating the new and conflicting scientific data on adverse events associated with the drug. FDA also requested Pfizer change the information provided to physicians to reflect the recommendations FDA made encouraging physicians to consider alternative therapies as they evaluate their individual patient needs. Pfizer agreed to suspend its Celebrex promotion and to craft appropriate detailing to physicians that reflects the uncertainty of scientific data currently available.

Common Side Effects of Celebrex

In addition to the serious side effects listed below, some common, but less serious side effects associated with Celebrex include: 

• Headache 
• Indigestion 
• Upper respiratory tract infection (a "cold") 
• Diarrhea 
• Sinus inflammation 
• Stomach pain 
• Nausea 

Who Should Not Take Celebrex

According to Pfizer, patients should not take Celebrex if they have aspirin-sensitive asthma, or allergic reactions to aspirin or other arthritis medicines or certain sulfa drugs called sulfonamides, or if they are in their third trimester of pregnancy.