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30 décembre, 2006 09:38 |
Vioxx On Trail
Key events involving the safety of the painkiller and a recap of the ensuing litigation.
May 1999
FDA approves Merck & Co.'s Vioxx, a Cox-2 inhibitor, for treatment of arthritis and acute pain in adults.
June 2000
Merck gives FDA results of VIGOR study, which shows Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen, sold under the brand name Aleve. Merck attributes the disparity to naproxen's cardioprotective qualities rather than a defect in Vioxx, but was rebuked by the FDA for making that assertion without scientific proof.
September 2001
Merck receives a warning letter from the FDA about the company's post-VIGOR Vioxx promotional campaign "that minimizes the potentially serious cardiovascular findings" and "misrepresents the safety profile of Vioxx."
