New Vioxx Label Warns of Increased Heart Attack Risk, FDA Says

WASHINGTON, D.C. - The FDA has ordered a change in the way Vioxx is labeled, adding a precaution for a higher risk of heart attacks and other cardiovascular events associated with the popular arthritis drug.

According to an FDA Talk Paper issued April 11, the regulatory agency has approved a supplemental application by Vioxx manufacturer Merck & Co. to add the new indication based on information it received following a study of nearly 4,000 patients prescribed 50 mg of the drug a day.

The study results, released by the Vioxx Gastrointestinal Outcomes Research (VIGOR), demonstrated that the Cox-2 inhibitor is …