STORY FROM: Drugs & Medical Devices
The Warnings Page: FDA Orders Stronger Warning on Vioxx Label; Consumer Group Petitions for Withdrawal of Arthritus Drug
May 7, 2002
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 ...