Mounting concern over the safety of the popular arthritis drugs Vioxx and Celebrex has arisen because of a single study done by Merck, the maker of Vioxx.
The study found that patients taking Vioxx had four times as many heart attacks as patients taking the arthritis painkiller naproxen, reports CBS News Correspondent Elizabeth Kaledin.
Dr. Michael Wolfe was on the Food and Drug Administration advisory panel that recommended approval of the drugs.
"The question is: Was the Vioxx causing the heart attacks or was the naproxen preventing the heart attacks? And that question hasn't been answered yet," he says.
In a statement, Merck says the FDA reviewed the data on Vioxx and says that in "ongoing clinical trials . . . there was no difference in the incidence of cardiovascular events such as heart attacks."
Pharmacia, the maker of Celebrex, claims its product is being unfairly lumped into the same category as Vioxx and that extensive studies show it is as safe as the class of drugs known as NSAIDs--nonsteroidal anti-inflammatory drugs.
"I feel confident that the data shows that the cardiovascular effects of Celebrex are no different from traditional NSAIDs and that it is indeed a safe compound," says Pharmacia's Dr. Steve Geis.
Still, the news may be unsettling to millions of people. The two drugs are among the companies' top sellers, netting them billions of dollars. They are aggressively marketed to a population most at risk for arthritis and heart disease--the elderly.
News of possible cardiovascular risks had calls from worried patients pouring in to Dr. Michael Belmont's office. He believes the drugs are safe but, "This issue about an increase in heart attack risk needs to be further studied."
In the meantime, the FDA advisory panel is urging the agency to put new warning labels on the two drugs telling people at risk for heart disease to avoid them. The FDA is now considering that recommendation.
©MMII CBS Worldwide Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed