Vioxx Timeline
1999
1999 -- Vioxx approved by
the United States Food and Drug Administration for treatment of osteoarthritis,
menstrual pain and acute pain in adults.
2001
May, 2001 --
Merck issues Press Release stating that Vioxx had a "favorable cardiovascular
safety profile." Later in September the FDA issues a severe warning
letter to Merck finding that Merck's representations in this Press Release
concerning Vioxx's safety were "simply incomprehensible" in
light of the known data that cardiovascular events were twice as likely
in Vioxx patients.
June, 2001 -- The Lancet, a medical journal,
publishes article that raises concerns over Vioxx and adverse affect on
kidneys.
August, 2001 -- The Journal of the American
Medical Association publishes results of extensive study involving more
than 8,000 patients that indicates that the heart attack rate for patients
taking Vioxx were "significantly" higher than for patients taking
a sugar pill (placebo). [Read
results of study here]
September 17, 2001 -- FDA issues serious
'warning letter' to Merck finding, among other things, that Merck's Press
Release of May 22, 2001, claiming that Vioxx did cause cardiovascular
side effects was "false" and that Merck's claim that Vioxx had
a 'favorable cardiovascular safety profile' was "simply incomprehensible".
This warning letter to Merck should be read to understand the blatant
disregard that Merck has exhibited for patient safety. [Read
September 17, 2001 warning letter.]
2002
June, 2002 -- Journal of Human Hypertension finds that treatment with Vioxx caused "a distinct increase in night-time systolic and diastolic BP."
2004
2004 -- Original
research article in Drugs & Aging publication finds that "In
an analysis of reporting rates, hospitalization for acute blood pressure
(BP) elevation was reported more frequently (3.8-fold) for rofecoxib [Vioxx]
compared with celecoxib [Celebrex]." This data was supported by the
clinical trial data that had previously been given to the FDA.
March 2004 -- Article published on Medscape
General Medicine (WebMD) outlines and recognizes that when Vioxx was introduced
and since then, "several discrepancies were noted in the presentation
of the actual trial results submitted to the US Food and Drug Administration
(FDA) and those used for the purpose of publication in scientific journals."
Many of these discrepancies relate to its adverse side effects.
September 30, 2004 -- Merck announces that it is withdrawing Vioxx
from the market. Approximately 2 million patients are taking Vioxx at
this time.
October, 2004 -- Case report published by
the Department of ophthalmology, Georgetown University, suggests that
oral rofecoxib may trigger Stevens-Johnson syndrome, potentially causing
symblepharons, corneal neovascularization and cicatricial ectropions.
[Link
to case report here]
