Painkiller Vioxx® Pulled from Market Alert
Sept 30, 2004 -- Merck & Co announced today that it was pulling its popular
arthritis and pain drug Vioxx (rofecoxib) from the worldwide market after a
clinical trial showed that the drug carried an increased risk for heart attacks
and strokes.
The increased cardiovascular risk was discovered during a trial to evaluate
the effect of Vioxx in preventing recurrence of colorectal polyps. After 18
months of treatment, the patients taking Vioxx were found to be at greater risk
for heart attack and stroke compared with those taking a placebo. The trial is
being stopped.
Vioxx is a COX-2 selective nonsteroidal antiinflammatory drug (NSAID). Other
COX-2 selective NSAIDs on the market at this time are Celebrex (celecoxib) and
Bextra (valdecoxib) NOTE: April 7, 2005, Pfizer agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the with the FDA. For more information, please read the
FDA press release.
. Vioxx is also related to the nonselective NSAIDs, such as
ibuprofen and naproxen.
Comment: The FDA today stated: "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."
The following is the public health advisory released today by the FDA and the
press release today from Merck & Co.
Barbara K. Hecht,
Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com
Related Links
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 nonsteroidal
antiinflammatory 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."
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