Pfizer has announced that a new study has shown that the popular arthritis drug Celebrex (search) more than doubles the risk of having a heart attack.

What is Celebrex?

Celebrex is a nonsteroidal anti-inflammatory drug (search), commonly referred to as an NSAID. NSAIDs are a large group of drugs that include aspirin, ibuprofen, and naproxen. But these older NSAIDs have not been associated with an increase in heart attacks. Celebrex works by reducing substances that cause inflammation, pain, and fever in the body and is used to treat osteoarthritis, rheumatoid arthritis, and other painful conditions.

Is Celebrex related to Vioxx, which was removed from the market?

Yes. Celebrex and Vioxx (search) are both members of the new class of NSAIDs called Cox-2 inhibitors (search). Vioxx was removed from the market on Sept. 30 because it was associated with an increase in heart attacks and strokes in people who took the drug for at least 18 months.

Bextra (search), another Cox-2 inhibitor, had a heart warning added to its label earlier this month after it was shown to increase heart problems in people undergoing heart bypass surgery.

What should I do if I am taking Celebrex?

Each patient needs to talk to his or her doctor to weigh the benefits of Celebrex against the risks of the drug. Though the current study shows an increase in heart attacks associated with Celebrex, other research has not found such an effect. Any decision about which drug to take to treat your symptoms should be made with the help of your doctor.

How did Pfizer find out this information?

The new results come from a study called the Adenoma Prevention with Celecoxib (APC) trial. This study was being conducted to examine the possible cancer-prevention effects of Celebrex in people at high risk of developing colon cancer. Celebrex has been shown to have some cancer prevention abilities in other studies. In this new study, patients taking 400 mg or 800 mg of Celebrex daily had an approximately 2.5-fold increase in their risk of experiencing a major fatal or nonfatal heart attack compared with those patients taking a placebo. Based on these findings, the sponsor of the trial, the National Cancer Institute, has stopped the study.

Have other studies shown this same heart risk with Celebrex?

Several studies have looked at the heart risks associated with Celebrex, but experts want to see more research. Just two weeks ago, a study showed that Celebrex did not seem to carry the same heart attack risk as Vioxx. Other ongoing research is continuing to look at the potential for heart risks from Celebrex.

By Michael W. Smith, reviewed by Charlotte E. Grayson, MD

SOURCES: FDA. News release, Pfizer.