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GENERAL INFORMATION |
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Vioxx
Dangers, Vioxx Recall and Vioxx Suit
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- Early 2001: FDA Meets To Discuss
Findings
At a meeting of an FDA advisory panel,
Merck argues that the trial results might
reflect the protective effects of naproxen
and not danger from its drug. The committee
ends up recommending that the issue be noted
on Vioxx's label, and members call for follow-up
research to clear up the questions.
- February 2001: FDA Approves Vioxx
Re-Labeling
FDA Approves Merck request to label Vioxx as safer on the stomach than older
painkillers, giving the drug a slight but important edge over Celebrex.
- August 2001: Further Examination
of Vioxx Adverse Effects Published
Doctors at the Cleveland Clinic examine data from several trials of Vioxx
patients and publish their findings in the Journal of the American Medical
Association, claiming the “available data raise a cautionary flag
about the risk of cardiovascular events" with Cox-2 inhibitors, especially
Vioxx.
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- September 17, 2001: FDA Letter Warns
Merck on Advertising and Vioxx Side Effects
In an eight-page letter to Merck Chief
Executive Raymond Gilmartin, the FDA warns
Merck for engaging "in a promotional campaign
for Vioxx that minimizes the potentially serious
cardiovascular findings that were observed" in
a clinical trial comparing Vioxx to naproxen,
a less-expensive painkiller. "Your promotional
campaign discounts the fact" that in the
trial, "patients on Vioxx were observed
to have a four to five-fold increase" in
heart attacks, compared with patients on naproxen,
the letter said.
- April 2002: FDA Approves New Vioxx
Labeling
The FDA, following up on the advisory
panel's advice from the year before, approves
new labeling for Vioxx that points out the
association with higher heart-attack and stroke
risk.
- 2003: High Volume of Vioxx Sales
Worldwide sales of Vioxx reach $2.5
billion.
- October 2003: Merck Study Finds Increased
Vioxx Risk
Merck-funded study finds patients taking Vioxx are at a 39% increased
risk of heart attack within the first ninety days, compared with Celebrex.
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