Merck & Co. has removed its blockbuster arthritis drug Vioxx from the market worldwide because new data from a clinical trial found an increased risk of heart attack and stroke. Merck decided to remove the drug from the market after data from the trial showed an increased risk of heart attack, stroke, blood clots and other cardiovascular complications.
Vioxx, also known as rofecoxib, was approved by the FDA
on November 2001 and went to market in March 2002. Vioxx is
made by Merck.
Vioxx is prescribed for the relief of symptoms of:
primary dysmennorhea (severe menstrual cramping)
Vioxx Side Effects
The European Medicines Evaluation Agency (EMEA) has issued
a warning alerting patients of serious side effects associated
with valdecoxib (Vioxx).
In November 2002, the U.S. Food and Drug Administration
(FDA) issued a warning about Vioxx. The FDA has received
about 20 reports of serious reactions among Vioxx users
since sales began. The FDA also mandated product label changes
for Vioxx. Merck, the manufacturer of Vioxx,
sent letters to thousands of physicians alerting them to
the new warnings.
A large study sponsored by Merck last year showed that
patients taking Vioxx had four times the risk of heart attacks
and that the risk appears to increase over time. Doctors
are worried about the possibility of heart attacks because
many of the arthritis patients taking Vioxx are elderly
and have a higher risk of cardiovascular problems to begin
with. While Vioxx does seem to cause fewer serious ulcers,
FDA medical officers say the potential safety advantage
is being offset by a higher risk of heart problems due to
an excess of serious cardiovascular events.
In a study of more than 8,000 patients that compared the
COX-2 inhibitor rofecoxib (Vioxx) with the traditional NSAID
naproxen, the risk of cardiovascular problems, including
heart attack, chest pain related to heart disease, stroke,
sudden death and blood clots, was more than two times higher
in the rofecoxib group than in the naproxen group.
Vioxx and Heart Attacks
Recent studies have shown that Vioxx can increase the incidence
of heart attack nearly four times greater than that of traditional
arthritis pain relievers like NSAIDS. More specifically,
the new study out of the Cleveland Clinic noted an increase
in the development of myocardial infarctions, or heart attacks,
in people treated with Vioxx, when compared with those treated
with naproxen (a standard NSAID). While the risk of heart
attack is still low, it is a concern for those users who
may have had cardiac problems in the past.
Other Cox-2 Inhibitors - Bextra, Celebrex
Vioxx and Heart Attacks
