Food & Drug Administration
Date created: September 30, 2004
What action did Merck take today?
Merck announced a voluntary
worldwide withdrawal of Vioxx (rofecoxib).
2. What is
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
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
FDA did not request a recall
of Vioxx. This product is being voluntarily withdrawn from the market by
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: