Q: What is Vioxx?
A: Vioxx is a COX-2 selective nonsteroidal anti-inflammatory drug
(NSAID). Vioxx is also related to the nonselective NSAIDs, such as
ibuprofen and naproxen. Vioxx is a prescription medicine used to relieve
signs and symptoms of arthritis, acute pain in adults, and painful
menstrual cycles.
Q: What is the most important information I should know about
Vioxx?
A: On September 30, 2004, Merck & Co., Inc., the manufacturer of
Vioxx, announced a voluntary withdrawal of the arthritis and pain relief
drug from the worldwide drug market, after results from a recent
clinical trial indicated that Vioxx users may have an increased risk of
suffering a heart attack, stroke, or other cardiovascular event. Merck's
action was not ordered by the U.S. Food and Drug Administration (FDA),
but was initiated by Merck based on its own findings from the clinical
trial. You can read the Vioxx withdrawal press release from Merck
here.
Q: Did the FDA take any action in connection with Vioxx's
withdrawal from the market?
A: FDA issued a public health advisory concerning the use of
Vioxx. This advisory is based on Merck & Co., Inc. voluntarily
withdrawing Vioxx from the market due to safety concerns. You can read
the FDA's Public Health Advisory on Vioxx
here.
Q: Does Merck's action in withdrawing Vioxx suggest that other
drugs in the same class are dangerous?
A: The results of clinical studies with one drug in a given class
do not necessarily apply to other drugs in the same class. All of the
NSAIDs have risks when taken chronically, especially of gastrointestinal
(stomach) bleeding, but also liver and kidney toxicity. Patients using
these drugs for a long period of time (longer than two weeks) should be
under the care of a physician.
Q: What have been the most serious health concerns raised
regarding Vioxx?
A: Vioxx has been linked to possible cardiovascular
complications, including blood clots, heart attacks and strokes, and to
kidney failure. Besides the known cardiovascular risks associated with
Vioxx, which prompted Merck to pull the drug from the marketplace, other
serious side effects can occur during treatment with this medicine.
Notify your doctor immediately if you develop abdominal pain,
tenderness, or discomfort; nausea; blood in your vomit; bloody, black,
or tarry stools; unexplained weight gain; swelling or water retention;
fatigue or lethargy; a skin rash; itching; yellowing of your skin or
eyes; "flu-like" symptoms; or unusual bruising or bleeding.
Q: Can a pharmacist continue to fill my prescription for Vioxx?
A: No, Merck is initiating a market withdrawal in the United
States to the pharmacy level. This means Vioxx will no longer be
available at pharmacies.
Q: What other drugs are similar to Vioxx?
A: Vioxx is a COX-2 selective, nonsteroidal anti-inflammatory
drug (NSAID). Other COX-2 selective NSAIDs on the market at this time
include Celebrex* (celecoxib). Vioxx is also related to the nonselective
NSAIDs, such as ibuprofen and naproxen. You should consult your
physician to determine which treatment is right for you.
(*Note: in April 2005, FDA required that Celebrex packaging carry stricter warnings of heart attack and stroke risk associated with use of Celebrex.)
Q: What should I tell the doctor if I suspect I have arthritis?
A: The following include some of the things you should tell your
doctor: where you have pain or stiffness; when you have pain or
stiffness; what the pain feels like (sharp/stabbing, dull/aching); how
long the pain lasts; how long you have had the pain; what tasks you find
difficult to do now; if you ever injured your joints or overused them in
a job or a hobby; if anyone in your family had problems similar to
yours; if you exercise, what kind of exercise you do and how often you
do it.
Q: What questions should I ask before leaving the doctor's office
for treatment of arthritis?
A: What can I do to help relieve my pain and live more
comfortably? What are the advantages and disadvantages of my various
treatment options? When might I expect to start feeling better? What can
I expect over the coming months/years? Under what circumstances should I
call your office?
Q: What should I do if I think I have been injured as a result of
taking Vioxx?
A: If you have experienced unusual side effects after taking
Vioxx, you should consult your physician immediately. Thereafter, you
might want to contact an attorney experienced in product liability
litigation to discuss potential legal claims you might have to recover
for injuries Vioxx caused you.
Q: How could I succeed in suing the manufacturer of a drug like
Vioxx?
A: While all medications have certain, anticipated side effects,
a drug manufacturer has a duty to make its pharmaceutical products as
reasonably safe as possible, and to inform the medical community and the
public of known risks associated with its drugs. If a manufacturer fails
to do so, it can be held responsible to patients who are injured as the
result of inadequate warnings or the unreasonably dangerous nature of
the drug, under a legal theory called “product liability”.
This includes material from the U.S. Food and Drug Administration