ARTICLE | Company News

FDA warns Merck on Vioxx promotion

September 24, 2001 7:00 AM UTC

FDA has repeated assertions that Merck's promotion and marketing of Vioxx is misleading and has requested that the company contact physicians to warn them that the COX-2 inhibitor could increase the risk of adverse cardiovascular effects. In a warning letter, FDA stated that Merck has "engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile of Vioxx." The agency also stated that Merck has minimized a potentially serious interaction between Vioxx and the drug Coumadin, has made unsubstantiated claims about the relative benefit of Vioxx and has promoted unapproved uses including the treatment of rheumatoid arthritis. ...