Vioxx: Higher Dose Increases Risk of Serious Heart Problems

FDA Kaiser Permanente Study

In August 2004 it was reported a large study financed by the U.S. FDA found that patients taking the highest recommended daily dosage of Vioxx (50mg) had three times the risk of heart attack and sudden cardiac death as those not taking standard painkillers.

Sudden cardiac death is an electrical disturbance of the heart that is not considered a heart attack.

Another major finding was that patients taking the typical starting dose of Vioxx (25mg) had a 50% greater chance of heart attack and sudden cardiac death than patients taking any dose of Celebrex.

This study was initiated by the FDA and funded by an agency contract with Kaiser Permanente. The lead author of the study, David Graham, was a medical officer in the FDA's Office of Drug Safety. When asked at the time if the FDA might consider banning use of high-dose Vioxx, given the study's findings, Graham replied, "The FDA has to decide whether they think a three-fold increase in heart attacks outweighs the benefits of the drug." As is typical for research performed by FDA staffers, however, the study had a disclaimer indicating that it did not reflect the official views of the FDA.

It was thought that the findings of this study might increase pressure on the FDA and Merck, the manufacturer of Vioxx, to consider adding stronger warning language for Vioxx. When the study results were reported in August 2004 the Vioxx warning label stated under the "Precautions" section that "caution should be exercised when Vioxx is used in patients" with a history of heart disease, and offered some data about that issue.

Merck, however, never did change the warning label from that time until when Vioxx was voluntarily withdrawn by Merck in late September 2004 due to safety concerns about the increased risk of heart attack in users.

Read more on our Vioxx Information Page >>