Vioxx Recall (Rofecoxib)
Vioxx, known generically as rofecoxib, was recalled in on October 1 in
the largest prescription drug withdrawal in history. The withdrawal was
prompted after a new study examining Vioxx's impact on bowel cancer found
the drug caused an almost twofold increase in heart attacks and strokes.
Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib)
from the U.S.worldwide. Merck & Co., Inc says this is 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.
The risk that an individual patient taking Vioxx will suffer a heart
attack or stroke related to the drug is very small. Patients who are currently
taking Vioxx should contact their physician for guidance regarding discontinuation
and alternative therapies.
Why is this medication prescribed?
Rofecoxib is used to relieve the pain, tenderness, inflammation (swelling),
and stiffness caused by arthritis and to treat painful menstrual periods
and pain from other causes. Rofecoxib is in a class of nonsteroidal anti-inflammatory
medications (NSAIDs) called COX-2 inhibitors. It works by stopping the
body's production of a substance that causes pain and inflammation. COX-2
inhibitors may cause less stomach bleeding and ulcers than similar medications.
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:
Visit www.fda.gov/medwatch and click on "How to Report"
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