FDA reports Vioxx serious adverse reactions

Medical Marketing and Media, Jul 2000 by Dickinson, James G

The FDA in May posted to its web site new serious adverse reaction data that were added March 17 by Merck to the labeling of its Cox-2 arthritis drug Vioxx (rofecoxib). The adverse reactions have a reported incidence of less than one percent. Earlier, after Merck had already revised Vioxx's labeling, the FDA indicated that newly reported serious cardiac adverse reactions to Vioxx that were more numerous than reactions to naproxen did not yet justify new labeling revisions.

The label revisions include changes to the following sections: cardiovascular, gastrointestinal, hemic and lymphatic, and urogenital system. New subsections were added: psychiatric, immune system, and nervous system. The agency also reported a change in the drug interaction section of the labeling relating to use of Vioxx with warfarin.