A number of health concerns surrounded
the prescription medication Vioxx, a drug used to
relieve osteoarthritis pain until is was removed from
the market in 2004. Vioxx is a NSAID (non-steroidal
anti-inflammatory drug) and is in the prescription drug
family commonly known as "Cox-2 Inhibitors." Although
Vioxx treated arthritis pain, this drug medication had
serious side effects, some of which were fatal.
Vioxx has been linked to the increased
risk of blood pressure problems, heart attacks and
strokes. Studies showed that Vioxx almost quadruples the
risk of heart attacks. In addition to these
life-threatening side effects, the side effects of Vioxx
can also include kidney and liver damage, high blood
pressure and stomach ulcers.
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People seeking arthritis pain relief
should carefully evaluate drug medication information
and side effects before deciding to take arthritis
medication drugs. It is important to note that just
because a drug is FDA approved and doctor prescribed
does not mean that the drug is safe. Vioxx clearly
proves this point.
Vioxx FDA Warnings:
In 2001 the Food and Drug Administration ordered Vioxx
manufacturer Merck "to correct false or misleading
impressions and information" stemming from a promotional
campaign aimed to minimize the known and potential
cardiac risks of Vioxx. Below is an excerpt of the Sept.
2001 letter sent to Merck from the FDA. "You have
engaged in a promotional campaign for Vioxx that
minimizes the potentially serious cardiovascular
findings that were observed in the Vioxx
Gastrointestinal Outcomes Research (VIGOR) study, and
thus, misrepresents the safety profile for Vioxx.
Specifically, your promotional campaign discounts the
fact that in the VIGOR study, patients on Vioxx were
observed to have a four to five fold increase in
myocardial infarctions (MIs) compared to patients on the
comparator non-steroidal anti-inflammatory drug (NSAID),
Naprosyn (Naproxen)...You have also engaged in
promotional activities that minimize the Vioxx /
Coumadin (warfarin) drug interaction, omit important
risk information, make unsubstantiated superiority
claims against other NSAIDs, and promote Vioxx for
unapproved uses and an unapproved dosing regimen. In
addition, in misrepresenting the Vioxx / warfarin drug
interaction you also misrepresent Vioxx's safety profile
by minimizing the potentially serious risk of
significant bleeding that can result from using Vioxx
and warfarin concomitantly. Your minimizing the
potential risks and misrepresenting the safety profile
for Vioxx raise significant health and safety concerns.
Your misrepresentation of the safety profile for Vioxx
is particularly troublesome because we have previously,
in an untitled letter, objected to promotional materials
for Vioxx that also misrepresented Vioxx's safety
profile."
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Also in 2001, the American Heart
Association, the National Stroke Association and the
Arthritis Foundation asked Merck & Co. to further test
Vioxx and its associated risk of heart disease and
stroke." In 2002 Merck strengthened the warnings,
precautions and clinical studies section of the Vioxx
labeling to include new cardiovascular and
gastroenterological safety information.
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