Were there any warning flags that led to Mercks recall of Vioxx?
Ever since the FDA sent a warning letter to Merck in 1999 calling Merck’s promotional materials “false and misleading,” and when the FDA directed Merck to send a letter to healthcare professionals with warnings involving the safety of its medication in 2002, Vioxx was headed for trouble. It’s no surprise Merck finally decided to pull the plug, and on September 30, 2004, Merck withdrew Vioxx from the shelves. The timeline below shows the warning flag that led to the Vioxx drug recall: ? May 14, 1999. The Food and Drug Administration (FDA) approved the drug Vioxx manufactured by Merck, Inc., for relief of the signs and symptoms of osteoarthritis, the management of acute pain and the treatment of primary dysmenorrheal (menstrual cramping). ? December, 1999. The FDA sent warning letters to Merck regarding misrepresentation of safety information in promotional material, calling the material “false and misleading.” ? November 23, 2000. An article in the New England Journal of Medicine report
