| Vioxx FDA
Talk Paper: The Withdrawal of Vioxx
FOR IMMEDIATE RELEASE
P04-95
September 30, 2004
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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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