Pharmaguy's Insights Into Drug Industry News

The drugs seemed miraculous when they were introduced in 1999, and they soon became blockbusters, with billion-dollar sales. Vioxx, made by Merck, and Celebrex, made by Pfizer, could quell pain and inflammation just as well as drugs like ibuprofen and naproxen, but they did not cause ulcers and gastrointestinal bleeding.

But then, the shocker. A Merck clinical trial asking if Vioxx could also prevent colon cancer revealed that the drug increased the risk of heart attacks, and the company pulled it off the market in 2004. Ever since, a question has hung over Celebrex. Did it cause heart attacks, too?

A decade ago, the Food and Drug Administration asked Pfizer to find out. Now, at long last, the resulting clinical trial is done. Most medical researchers, including the study’s principal investigator, thought Celebrex would be riskier than either ibuprofen or naproxen. Instead, it was at least no worse and may even be safer than the alternatives.

“This is definitely a striking finding,” said Dr. Michael Lauer, a cardiologist at the National Institutes of Health who was not associated with the study.

An estimated two million people in the United States take Celebrex or generic celecoxib, said Dr. Milton Pressler, a cardiologist in charge of clinical affairs for Pfizer Essential Health. The drug is available only by prescription; as the trial dragged on its patent expired, so now generic companies also sell it.

The study involved 24,000 people with arthritis who were at high risk for heart disease or already had it. A third of them were randomly assigned to take Celebrex, a third to take naproxen and a third to take ibuprofen. The doses were equivalent and neither the participants nor the investigators knew who was taking what.

The results were published online in the New England Journal of Medicine on Sunday to coincide with a presentation at the annual meeting of the American Heart Association by Dr. Steven Nissen of the Cleveland Clinic, who directed the new study.

He and others emphasized that the findings apply only to people taking the drugs every day for months or years and who are at high risk for heart disease or already have it. They do not apply to someone who pops an occasional ibuprofen like Advil for a pulled muscle or takes a naproxen such as Aleve for a headache.