VIOXX

On September 17, 2001, the Food and Drug Administration issued a Warning Letter to the Merck & Co. Inc, the manufacturer of Vioxx, directing the company to cease certain promotional marketing due to "false, lacking in fair balance, or otherwise misleading" advertising and materials "in violation of the Federal Food, Drugs and Cosmetic Act and applicable regulations".

The FDA determined that Merck "engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research".
Since the September 2001 warnings, reports have been published in several medical journals concerning the side effects of Vioxx. The Journal of American Medicine reported that Vioxx users are at significantly higher risk of cardiovascular problems.

In May 2002, the U.S. Food and Drug Administration published a Talk Paper about new label warnings for the popular arthritis and pain drug know as Vioxx (Rofecoxib). The new label warnings are based on the results of the Vioxx Gastrointestinal Outcomes Research (VIGOR). Studies indicate that people taking Vioxx have four times the risk of heart attack.