Additional Information
- Side Effects of Vioxx
- Timeline of Events
- Frequently Asked Questions
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Timeline of Events
May 1999 - Vioxx is approved by the United States Food and Drug Administration for treatment of osteoarthritis, menstrual pain, and acute pain in adults
March 2000 - Merck reveals that the VIGOR study found Vioxx patients had double the rate of serious cardiovascular problems than those on Naproxen (an older nonsteroidal anti-inflammatory drug or NSAID). Merck attributed the difference to the protective effect of Naproxen.
May 2001 - Merck issues Press Release stating that Vioxx had “a favorable cardiovascular safety profile”
August 2001 - The Journal of the American Medical Association publishes results of a study by the Cleveland Clinic that indicated that the heart attack rate for patients taking Vioxx were significantly higher than that for patients taking a sugar pill (placebo)
September 2001 - The FDA issued a severe warning letter to Merck finding that Mercks’s representations in the May, 2001 press release concerning Vioxx’s safety were “simply incomprehensible in light of the known data that cardiovascular events (such as heart attacks) were twice as likely in Vioxx patients
April 2002 - The FDA tells Merck to change its Vioxx label to include information about the cardiovascular risks from the VIGOR study
October 2003 - Merck study finds 39% increased risk within first 90 days when compared to Celebrex
September 2004 - Merck says it just learned that patents taking Vioxx were twice as likely to suffer a heart attack or stroke as those on placebo
September 30, 2004 - Merck pulls Vioxx off of the market. It is estimated that 2 million people are taking Vioxx when it is recalled.
