How much information did the Food and Drug Administration have about the risks involving strokes and heart attacks when it approved Vioxx?
In the original safety database, there were about 5000 patients taking Vioxx and none of them displayed any increased chances of having a stroke or heart attack. In May 1999, the Food and Drug Administration approved Vioxx. VIGOR, a study that was submitted to the FDA in June 2000 was conducted to look at Vioxx’s effect on certain side effects, such as bleeding and stomach ulcers. VIGOR, also known as VIOXX GI Outcomes Research, revealed that patients who took Vioxx bled less and didn’t have as many stomach ulcers as people taking another type of NSAID called Naproxen. The study did indicate, though, that more Vioxx patients had suffered heart attacks. This information was talked about in 2001 by the Arthritis Advisory Committee and was included on Vioxx labels beginning April 2002. After this, Merck & Company started conducting other trials to find out more information about Vioxx and its connection to strokes and heart attacks.
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