Heart Attack Risks

In addition to kidney failure, researchers are concerned about the increased the risk of heart attacks. In February, the FDA's arthritis drugs advisory committee analyzed COX-2 inhibitors cardiovascular risks. Merck presented a study to support its contention that Vioxx is safer on the gastrointestinal tract than other NSAIDs. Although the study found that Vioxx reduced the incidence of ulcers and other gastrointestinal problems by about half that of the over-the-counter NSAID Aleve, the study showed that people taking Vioxx had four times the risk of a heart attack.

However, Merck claims their Vioxx studies show no evidence that the drug increases the risk of a heart attack compared with other NSAIDs. The company claims that Vioxx has little effect on the heart. They claim that the study appeared to increase the risk of a heart attack because Aleve the drug in the study, like aspirin, actually reduces heart attack relative to people on Vioxx.

The FDA is considering changing the label of Vioxx to highlight the potential for heart problems.

In February an FDA panel concluded Vioxx should retain its strong warning that it can cause ulcers like the older, less expensive painkillers - the panel also concluded that doctors and patients should be warned that it might carry a heart attack risk. The panel said patients and doctors must be warned that in the study, Vioxx patients had more than twice the risk of heart attacks or other cardiovascular side effects as traditional pain killers users.

FDA's advisers concluded that more research is needed but that Vioxx's label should warn of the concern and potential danger. Although the FDA isn't bound by its advisers' recommendations it usually follows them.