Was September 27, 2004 the first warning Merck & Co., Inc. had of problems with VIOXX®?
No. As far back as June 2000, Merck submitted to the FDA a safety study called VIGOR (VIOXX® Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking VIOXX® compared to patients taking naproxen. In August 2001, VIOXX® was linked to an increase in the risk of blood clots, heart attacks and strokes based on a review and analysis of previous clinical trials. The FDA sent Merck a warning letter dated September 17, 2001. You can read the FDA’s warning letter issued to Merck & Co., Inc. here. The letter demanded that Merck discontinue promoting VIOXX® to doctors for unofficial uses. It also required Merck to send letters about the deception to the medical community. In April 2002, after reviewing the results of the VIGOR study and other available data from controlled clinical trials, the FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included
