Vioxx
(rofecoxib)
Source: FDA
Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib)
from the U.S. and worldwide market due to safety concerns of an increased risk
of cardiovascular events (including heart attack and stroke) in patients on
Vioxx. Vioxx is a prescription COX-2 selective, non-steroidal
anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the
relief of the signs and symptoms of osteoarthritis, for the management of acute
pain in adults, and for the treatment of menstrual symptoms. Vioxx was later
approved for the relief of the signs and symptoms of rheumatoid arthritis in
adults and children.
1.
What action did Merck take today? -(9/30/04)
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:
Date created: September 30, 2004
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