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Vioxx Facts & Answers |
Vioxx FAQs
 Vioxx is the name Merck &
Co. gave to rofecoxib, a non-steroidal anti-inflammatory drug (NSAID)
developed by the company in the 1990s.
Vioxx is classified as
a COX-2 inhibitor, a type of pain relief that works by inhibiting an
enzyme (cyclooxygenase) involved in inflammation.
In 1999, Merck
received FDA approval for Vioxx as a treatment for pain from
osteoarthritis, acute pain in adults, and menstrual pain.
Twelve percent of
adults in the United States (about 25 million people) reported
taking prescription drugs for arthritis, according to a July 2000
Kaiser poll.
Vioxx was seen by
industry analysts as a direct competitor to Celebrex, a COX-2
inhibitor manufactured by rival Pharmacia.
The most common side
effects from Vioxx were listed as upper-respiratory infections,
diarrhea, nausea and high blood pressure.
Since its
introduction, more than 91 million prescriptions for Vioxx have been
written in the United States alone.
Advertising to
consumers and physicians helped fuel the growth of COX-2 inhibitors.
In 2002, Merck spent $171 million to promote Vioxx to physicians,
while Pharmacia spent $133 million on Celebrex and another $120
million on Bextra.
Total U.S. sales of
COX-2 inhibitors (including Vioxx and Celebrex) were $4.5 billion in
2003.
Merck reported
worldwide sales of Vioxx reached $661 million for the first quarter
of 2004, an increase of 30 percent from the comparable prior year
period. In markets outside of the United States, Vioxx continues to
be the best-selling arthritis and pain medicine.
In 2000, while
studying Vioxx's gastrointestinal effect, Merck researchers noted
the patients taking Vioxx had a greater number of heart attacks than
those taking naproxen, another NSAID.
In September 2001, the
FDA issued a warning to Merck for misrepresenting the safety of
Vioxx by downplaying the cardiovascular risks associated with the
drug's use. The following year, new safety information was added to
Vioxx labeling.
A Canadian study from
May 2004 investigated the safety of COX-2 inhibitors. Patients in
the study using Vioxx had an 80 percent increased risk of hospital
admission for congestive heart failure compared to those taking
Celebrex.
In August 2004, an
FDA-sponsored study reported patients taking the recommended
starting dose of Vioxx (12.5 mg) had a 50 percent greater risk of
heart attacks and sudden cardiac death than patients taking Celebrex.
The same study found patients taking the highest recommended dose
(50 mg) had three times the risk of heart attacks and sudden cardiac
death.
Most patients using Vioxx
take daily doses of 12.5 or 25 mg for arthritis. A 50 mg dose has
been approved by the FDA for the treatment of pain, but not for more
than five days.
Following the release
of the FDA study, Merck issued a statement that "strongly disagrees"
with the study's findings.
In September 2004, the
FDA approved Vioxx for juvenile rheumatoid arthritis, the first
COX-2 inhibitor to be approved for JRA.
Sources: Merck & Co., www.merck.com,
www.fda.gov, British Medical Journal, Cleveland Clinic Journal of
Medicine, ABC News Medical Unit
Vioxx FAQs
» What is Vioxx?
» Why did Merck take Vioxx off the market?
» How can an arthritis drug lead to heart attack
and stroke?
» What are the side effects of Vioxx?
» What does this mean for Celebrex or Bextra, the
other two drugs in the class known as COX-2 inhibitors?
» What can I take instead of Vioxx or Celebrex?
» What should I do if I am currently taking Vioxx?
» What should I do if I have been a victim of
prescription drugs?
» If I file suit against the manufacture of
Vioxx, what are my chances of winning?
» How common is pharmaceutical / prescription
negligence?
What is Vioxx?
Vioxx is a popular anti-inflammatory medication introduced to the U.S.
market in 1999, and used to be prescribed to ease the pain, swelling and
other symptoms of osteoarthritis. Before drugmaker Merck & Co. withdrew
it from the worldwide market September 30, 2004, it was most commonly
given to patients with Osteoarthritis. Vioxx belongs to a class of
medications known as cyclooxygenase-2, or COX-2, inhibitors. Sales
topped $2.55 billion in 2003.
Vioxx – a non-steroidal, anti-inflammatory drug (NSAID) – is in a class
of drugs commonly referred to as "Cox-2 Inhibitors". It comes in liquid
or pill form, and is prescribed to relieve the symptoms of
osteoarthritis. It can also be used to treat acute pain in adults such
as those patients who experience severe pain associated with
menstruation. Vioxx works by blocking COX-2 enzymes in the body that
trigger pain and inflammation.
Why did Merck take Vioxx off the market?
Merck pulled its best-selling arthritis drug off the market based on
data indicating the drug increases the risk of heart attack and stroke
among users.
Merck announced the immediate, voluntary worldwide withdrawal after a
three-year colon cancer clinical trial with 2,600 patients revealed that
18 months after patients started taking Vioxx, test results showed an
increased risk of heart attacks and other cardiovascular complications.
84 million people have used Vioxx since 1999.
In previous years, Merck consistently denied any possible links between
Vioxx and cardiovascular problems.
The drug was licensed in June 1999. Since then, more than 20 million
Americans have taken the drug at one time or another. In September 2001,
the FDA sent Merck an eight-page warning letter about the company’s
promotional campaign for Vioxx. The letter indicated that the campaign
minimized “the potentially serious cardiovascular findings that were
observed” in a trial that compared the drug to naproxen, a
less-expensive painkiller. The FDA charged that Merck discounted the
fact that "patients on Vioxx were observed to have a four to five-fold
increase" in heart attacks, compared with patients on naproxen.
How can an arthritis drug lead to heart attack and
stroke?
Scientists say they are not sure. However, several studies have
indicated that Vioxx and other COX-2 inhibitors are known to raise blood
pressure and increase the risk of heart attack. Drugs such as Vioxx and
Pfizer's Celebrex inhibit Cox-2, an enzyme that triggers pain and
inflammation.
Vioxx has also been associated with several other life-threatening side
effects, including blood clots, angina and nonbacterial meningitis,
severe intestinal damage, ulcerations and bleeding, and kidney damage.
What are the side effects of Vioxx?
Vioxx side effects may include, but are not limited to, heartburn, nausea,
diarrhea, upper respiratory tract infection, swelling of the lower
extremities (legs and/or feet), high blood pressure, itching, stomach
ulcers or bleeding, fatigue, vomiting, dark urine, and black stools.
In addition to increasing risk of heart attack and stroke, patients
taking Vioxx were found to be four times more likely to suffer from
heart attack than those taking Naproxen (Aleve). Vioxx is more likely to
cause severe intestinal damage, ulcerations and bleeding, blood clots
and toxic epidermal necrolysis (a fatal skin disease), than other
arthritis pain relievers.
Other health problems include:
- Serious kidney problems that could lead to acute kidney failure.
- Serious liver problems.
- Allergic reactions, such as swelling of the face, lips, tongue, and
throat which can cause difficulty breathing or swallowing.
- The FDA reports that Vioxx has also been linked to at least five cases
of a non-bacterial type of meningitis, a rare but serious side effect.
These conditions may come about suddenly with few or no symptoms. If
left untreated, hospitalization or even death can occur.
If you, or a loved one, have taken Vioxx and experienced any side
effects, contact our pharmaceutical negligence lawyers today, for a
free evaluation -
1.800.536.HELP
What does this mean for Celebrex or Bextra, the other
two drugs in the class known as COX-2 inhibitors?
In light of the Vioxx study findings, several top scientists have stated
that the finding of an elevated risk of heart attacks and strokes
applies to all COX-2 inhibitors. Clinical trials of Celebrex and Bextra
did not reveal the same problems as Vioxx because participants were
allowed to take aspirin, which has proved to reduce the risk of
cardiovascular problems.
Pfizer, maker of Celebrex and the less-prescribed Bextra, stands by its
products. But studies are continuing to review the link of these drugs
to cardiac problems.
More About Vioxx &
Celebrex >
What can I take instead of Vioxx or Celebrex?
Older medications like ibuprofen, naproxen or simply aspirin have been
used as alternatives for Vioxx and Celebrex.
What should I do if I am currently taking Vioxx?
Contact your doctor to discuss discontinuing use of Vioxx and possible
alternative medications. If you have experienced any side effects,
contact a lawyer to review your case. We understand your medical
concerns take priority, but don't ignore your legal right to
compensation.
Your state's law may limit your time to bring a legal claim. To protect
your rights, you need to have your personal injury claim evaluated
immediately.
Free Vioxx Case
Evaluation >
What should I do if I have been a victim of
prescription drugs / pharmaceutical negligence?
You may be experiencing pain and suffering and severe financial
hardships. You should not go through this difficult time alone. You, the
patient, should not be paying for your doctor's mistakes or negligence.
If you or a loved one are living with the consequences of the effects
from Vioxx, it is important to contact an experienced
lawyer who can protect your rights and get you the compensation to which
you are entitled.
Our Vioxx Lawyers have a track record of success representing your
rights against drug manufacturers. We are available to discuss your
potential claim, and answer any questions you might have. Call us for a
Free Case Evaluation :
1.800.536.HELP
If I file suit against the manufacture of Vioxx,
what are my chances of winning?
Every case is different; however, patients who were prescribed Vioxx and
experienced serious health conditions (such as a heart attack, stroke,
or kidney failure) because of it have an excellent chance to recover
monetary compensation for the losses that they have incurred.
There is evidence that suggests Merck knew of the health risks
associated with Vioxx, but continued to heavily market the arthritis
drug. Brown & Crouppen litigates your case against the giant drug
manufacturers. Have your claim evaluated today,
click here.
How common is pharmaceutical / prescription
negligence?
Prescription drug side effects, or Adverse Drug Events (ADE’s) result in
more than 550,000 injuries and over 100,000 deaths each year, according
to the Journal of the American Medical Association.
Nearly one out of every five medication doses given in hospitals and
nursing facilities is improperly dispensed or prescribed. More than 40
potentially harmful drug errors occur, on average, in hospitals on a
daily basis. (Archives of Internal Medicine).
In pediatric emergency rooms, according to statistics, doctors
misprescribe 4 in every 1,000 prescriptions written. (presented at the
American Academy of Pediatrics conference).
Unfortunately, pharmaceutical negligence/malpractice, by doctors and
pharmacists, is too common. The prescription drugs and victims of these
medications are widespread.
If you feel that you, or someone you love, has been injured by
prescription/pharmaceutical negligence, please contact us for a free
evaluation.
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