First Vioxx, Then Bextra, Now Celebrex?
by Donna Rae Siegfried

Another COX-2 Inhibitor Linked to Heart Attack Risk 

News of negative side effects from a popular class of drugs has been coming in quick bursts, like popcorn under heat. The first and most stunning news was the withdrawal of rofecoxib (Vioxx), which had been one of the country's top-selling drugs, after finding that it significantly increased risk of heart attacks and stroke. Then valdecoxib (Bextra) was linked to higher risks of heart attacks, stroke and a severe skin problem. Now celecoxib (Celebrex) is making news for possibly increasing the risk of heart attack at high doses or with long-term use. 

All three drugs are COX-2 inhibitors, a subset of nonsteroidal anti-inflammatory drugs (NSAIDs) designed to be gentler on the stomach than ordinary NSAIDs. 

In a study of people with colon polyps, Celebrex -- which is FDA-approved to treat an inherited condition in which precancerous polyps grow in the colon -- was being studied to see if it prevented progression from polyps to colon cancer. Some of the 1,056 people in the study received 400 milligrams (mg) or 800 mg of Celebrex per day -- two to four times the dose prescribed for OA or RA -- for an average of 33 months; others received placebo. Results showed the incidence of heart attack was 2.5 times higher in those taking 400-mg Celebrex and 3.4 times higher in those taking the 800-mg dose than in those taking placebo. The study was stopped immediately, as was a second colon cancer study using Celebrex. 

The cardiovascular risks of Celebrex aren't certain though. The second study was looking at whether Celebrex prevented the development of precancerous colon polyps. Data from the study, in which 933 people were taking a 400-mg dose of Celebrex for about three years, did not show an increase in heart attacks. A clinical study to gain more information on the use of Celebrex in people with OA who are at high risk for cardiovascular disease is being designed.