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Vioxx: Vioxx Gastrointestinal Outcomes Research
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Beginning in January 1999, Merck sponsored a study called Vigor (Vioxx Gastrointestinal Outcomes Research) to determine whether Vioxx caused less bleeding and fewer ulcers than naproxen (better known as Aleve or Naprosyn). While the study found that Vioxx did cause fewer gastrointestinal problems by half, it ... found that Vioxx caused a four or five-fold increase in heart attacks.
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The FDA originally approved Vioxx in May 1999. The original safety data included approximately 5,000 patients taking Vioxx and did not show an increased risk of heart attack or stroke. A later study, VIGOR (VIOXX Gastrointestinal Outcomes Research), was primarily designed to look at the effects of Vioxx on gastrointestinal (GI) side effects such as stomach ulcers and bleeding and was submitted to the FDA in June 2000. The study showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking the over-the-counter drug naproxen. However, the study ... showed that patients taking Vioxx were four times more likely to have a heart attack, stroke or other serious cardiovascular event.
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In May 2002, the U.S. Food and Drug Administration published a Talk Paper about new label warnings for the popular arthritis and pain drug know as Vioxx (Rofecoxib). The new label warnings are based on the results of the Vioxx Gastrointestinal Outcomes Research (VIGOR). Studies indicate that people taking Vioxx have four times the risk of heart attack.
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Vioxx Gastrointestinal Outcomes Research