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:
16. Where can I get more information?
You can obtain more information from Merck at:
To find out more about Vioxx from FDA:
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Date created: September 30, 2004 |