2004 in Review


The revelation in September that the popular arthritis drug rofecoxib (Vioxx) more than doubles the risk of myocardial infarction led to its withdrawal by Merck and to a reevaluation of the safety of other cyclooxygenase-2 inhibitors. In the aftermath, many have questioned why the Food and Drug Administration and Merck had not paid more attention to earlier results that also raised safety concerns.

Regardless of the conclusions reached by the various investigators, “More safety experience is going to be required, and there may be more cautionary labels not for what has been seen but for what is not known.

“The issues brought forth by Vioxx will ultimately drip down to almost everything we do. But we mustn't overlook the fact that a huge number of patients have taken the drug and been exposed to increased risk,” Barry Massie, M.D., chief of cardiology at the Veterans Affairs Medical Center, San Francisco, told CARDIOLOGY NEWS.