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Vioxx (rofecoxib)
Questions and Answers
1.
What action
did Merck take today?
Merck
announced a voluntary
worldwide withdrawal of
Vioxx (rofecoxib).
2. What is
Vioxx?
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.
3. Did FDA
require this action?
No, Merck
made this decision
independent of input from
FDA. The Agency has not had
an opportunity to review the
data from the study that was
stopped in the depth that
Merck has, but agrees with
the company that there
appear to be significant
safety concerns for
patients, particularly those
taking the drug chronically.
FDA plans to
work closely with Merck to
coordinate the withdrawal of
this product from the US
market.
4. What
action did FDA take today?
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.
5. What
should I do if I am
currently taking Vioxx?
The risk that
an individual patient will
suffer a heart attack or
stroke related to Vioxx is
very small. We encourage
people taking Vioxx to
contact their physician to
discuss discontinuing use of
Vioxx and alternative
treatments. Any decision
about which drug product to
take to treat your symptoms
should be made in
consultation with your
physician based on an
assessment of your specific
treatment needs.
6. What are
the likely long-term health
effects, if any, of taking
this product?
The new study
shows that Vioxx may cause
an increased risk in
cardiovascular events such
as heart attack and strokes
during chronic use.
7. What
evidence supports the Public
Health Advisory?
Merck’s
decision to withdraw Vioxx
from the market is based on
new data from a trial called
the APPROVe [ Adenomatous
Polyp Prevention on VIOXX]
trial. In the APPROVe
trial, Vioxx was compared to
placebo (sugar-pill). The
purpose of the trial was to
see if Vioxx 25 mg was
effective in preventing the
recurrence of colon polyps.
This trial was stopped early
because there was an
increased risk for serious
cardiovascular events, such
as heart attacks and
strokes, first observed
after 18 months of
continuous treatment with
Vioxx compared with placebo.
8. Why
wasn’t the APPROVe trial
stopped earlier?
The APPROVe
trial began enrollment in
2000. The trial was being
monitored by an independent
data safety monitoring board
(DSMB). It was not stopped
earlier because the results
for the first 18 months of
the trial did not show any
increased risk of confirmed
cardiovascular events on
Vioxx.
9. What did
FDA know about the risk of
heart attack and stroke when
it approved Vioxx?
FDA
originally approved Vioxx in
May 1999. The original
safety database included
approximately 5000 patients
on Vioxx and did not show an
increased risk of heart
attack or stroke. A later
study, VIGOR (VIOXX GI
Outcomes Research), was
primarily designed to look
at the effects of Vioxx on
side effects such as stomach
ulcers and bleeding and was
submitted to the FDA in June
2000. The study showed that
patients taking Vioxx had
fewer stomach ulcers and
bleeding than patients
taking naproxen, another
NSAID, however, the study
also showed a greater number
of heart attacks in patients
taking Vioxx. The VIGOR
study was discussed at a
February 2001 Arthritis
Advisory Committee and the
new safety information from
this study was added to the
labeling for Vioxx in April
2002.
Merck then
began to conduct longer-term
trials to obtain more data
on the risk for heart attack
and stroke with chronic use
of Vioxx.
10. Is FDA’s
expedited review process
putting riskier drugs on the
market?
No. Vioxx
received a six-month
priority review because the
drug potentially provided a
significant therapeutic
advantage over existing
approved drugs due to fewer
gastrointestinal side
effects, including
bleeding. A product
undergoing a priority review
is held to the same rigorous
standards for safety,
efficacy, and quality that
FDA expects from all drugs
submitted for approval.
11. What
other drugs are similar to
Vioxx?
Vioxx is a
COX-2 selective,
nonsteroidal
anti-inflammatory drug
(NSAID). Other COX-2
selective NSAIDs on the
market at this time are
Celebrex (celecoxib) and
Bextra (valdecoxib). 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.
12. Does
today’s action suggest that
other drugs in the same
class are dangerous?
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.
13. Will
Vioxx be recalled?
FDA did not
request a recall of Vioxx.
This product is being
voluntarily withdrawn from
the market by Merck.
14. Can my
pharmacist continue to fill
my prescription for Vioxx?
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.
15.
How can I
report a serious side effect
with Vioxx to FDA?
FDA
encourages anyone aware of a
serious adverse reaction to
make a MedWatch report. You
can report an adverse event
in two ways:
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