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An overview...
*The following article was release by the FDA.
All Rights Reserved.
FOR IMMEDIATE RELEASE P04-95 - September 30, 2004
FDA Issues Public Health Advisory on Vioxx as its Manufacturer
Voluntarily Withdraws the Product
"The Food and Drug Administration (FDA) today acknowledged
the voluntary withdrawal from the market of Vioxx (chemical name
rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured
by Merck & Co. FDA today also issued a Public Health Advisory
to inform patients of this action and to advise them to consult
with a physician about alternative medications.
Merck is withdrawing Vioxx from the market after the data safety
monitoring board overseeing a long-term study of the drug recommended
that the study be halted because of an increased risk of serious
cardiovascular events, including heart attacks and strokes, among
study patients taking Vioxx compared to patients receiving placebo.
The study was being done in patients at risk of developing recurrent
colon polyps.
"Merck did the right thing by promptly reporting these findings
to FDA and voluntarily withdrawing the product from the market," said
Acting FDA Commissioner Dr. Lester M. Crawford. "Although the risk
that an individual patient would have a heart attack or stroke
related to Vioxx is very small, the study that was halted suggests
that, overall, patients taking the drug chronically face twice
the risk of a heart attack compared to patients receiving a placebo."
Dr. Crawford added that FDA will closely monitor other drugs in
this class for similar side effects. "All of the NSAID drugs have
risks when taken chronically, especially of gastrointestinal bleeding,
but also liver and kidney toxicity. They should only be used continuously
under the supervision of a physician."
FDA approved Vioxx in 1999 for the reduction of pain and inflammation
caused by osteoarthritis, as well as for acute pain in adults and
for the treatment of menstrual pain. It was the second of a new
kind of NSAID (Cox-2 selective) approved by FDA. Subsequently,
FDA approved Vioxx to treat the signs and symptoms of rheumatoid
arthritis in adults and children.
At the time that Vioxx and other Cox-2 selective NSAIDs were approved,
it was hoped that they would have a lower risk of gastrointestinal
ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen).
Vioxx is the only NSAID demonstrated to have a lower rate of these
side effects.
Merck contacted FDA on September 27, 2004, to request a meeting
and to advise the agency that the long-term study of Vioxx in patients
at increased risk of colon polyps had been halted. Merck and FDA
officials met the next day, September 28, and during that meeting
the company informed FDA of its decision to remove Vioxx from the
market voluntarily.
In June 2000, Merck submitted to FDA a safety study called VIGOR
(Vioxx Gastrointestinal Outcomes Research) that found an increased
risk of serious cardiovascular events, including heart attacks
and strokes, in patients taking Vioxx compared to patients taking
naproxen. After reviewing the results of the VIGOR study and other
available data from controlled clinical trials, FDA consulted with
its Arthritis Advisory Committee in February 2001 regarding the
clinical interpretation of this new safety information. In April
2002, FDA implemented labeling changes to reflect the findings
from the VIGOR study. The labeling changes included information
about the increase in risk of cardiovascular events, including
heart attack and stroke.
Recently other studies in patients taking Vioxx have also suggested
an increased risk of cardiovascular events. FDA was in the process
of carefully reviewing these results, to determine whether further
labeling changes were warranted, when Merck informed the agency
of the results of the new trial and its decision to withdraw Vioxx
from the market."
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