Could Vioxx Dangers Been Spotted Sooner?
In May 1999 the Food and Drug Administration (FDA) approved Vioxx. The original safety database included approximately 5,000 patients on Vioxx and did not show an increased risk of heart attack, stroke, blood clots, or sudden death. One year later in June 2000, Merck submitted a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) to the FDA that found an increased risk of Vioxx heart attacks and strokes in patients taking Vioxx compared to patients taking naproxen. After reviewing the VIGOR study results and other available data from controlled clinical trials, the FDA consulted with its Arthritis Advisory Committee in February 2001 regarding the clinical interpretation of this new questionable Vioxx-related information. Fourteen months later in April 2002, the FDA implemented labeling changes to reflect findings from the VIGOR study. These labeling changes included information about the increase of Vioxx heart attack and stroke risks. Why did it take 22 months to aler
