Vioxx (rofecoxib)
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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 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 |
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