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FDA
News
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.
Additional information about this withdrawal of Vioxx, as
well as questions and answers for patients, is available
online at
http://www.fda.gov/cder/drug/infopage/vioxx/default.htm.
http://www.fda.gov/bbs/topics/news/2004/NEW01122.html
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