Vioxx maker Merck & Co. pulled Vioxx from
the market worldwide in 2004 amid concerns that Vioxx
sharply increases the risk of heart attack, stroke and
sudden cardiac death.New data
from a clinical trial found an increased risk of heart
attack and stroke, mirroring the results of numerous
other 2004 studies that showed similar increased risks
of heart attack and stroke. Merck spokesmen Thursday
said data from the trial showed heart attack risks and
other cardiovascular complications surfaced in patients
18 months after starting Vioxx.
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Merck is the world's third-biggest
drug maker. Vioxx sales totaled $2.55 billion worldwide
in 2003. In the United States alone, 91 million Vioxx
prescriptions have been written. Vioxx is currently used
by two million people worldwide and over 84 million
people have used the medication since its introduction
in 1999.
Vioxx is part of a class of
anti-inflammatory drugs called cox-2 inhibitors. Cox-2
inhibitors are heavily touted by the pharmaceutical
industry as being more effective with less side effects
than older arthritis drugs.
However; "In terms of pain relief, these drugs are no
better than ibuprofen and they cost 10, 15 times more,"
said independent health care analyst Hemant Shah of HKS
& Co. in Warren, N.J. Shah also said physicians prefer
ibuprofen more than Celebrex and Vioxx combined.
Heart attack and other heart
complications have been a looming concern for Vioxx and
other Cox-2 inhibitors.
According to a large study financed by
the FDA, patients taking Vioxx had a 50 percent greater
chance of heart attack and sudden cardiac death than
individuals using Celebrex. The 2004 study also found
patients taking the highest recommended daily dosage of
Vioxx had three times the risk of heart attack and
sudden cardiac death as those not taking standard
painkillers.
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Researchers, after analyzing the
medical records of 1.4 million people insured by Kaiser,
found that 8,199 heart attacks and cases of sudden
cardiac death occurred between 1999 and 2001 among
patients taking Vioxx.
Canadian researchers in May (2004) reported an increased
risk for heart attack and heart disease among elderly
people using Vioxx that wasn't noted in those taking its
rival, Celebrex. This study, published in “The Lancet,”
reported that those taking Vioxx were 80 percent more
likely to be admitted to the hospital with heart attack
and heart problems.
Researchers at the Arthritis Research
Center Foundation examined data on 8,500 patients.
Patients taking Vioxx were 21 percent more likely to
develop the heart problem of high blood pressure and 23
percent more likely to develop leg swelling than those
taking Celebrex. This study was published in the June
2004 issue of the “Journal of Rheumatology.”
Although most of the heart attack
focus has been connected with Vioxx, the withdrawal of
Vioxx casts a cloud over the entire class of widely used
COX-2 inhibitors.
An article in the August 2004 issue of the "Journal of
the American Medical Association" reanalyzed old data to
suggest that there might be heart attack problems with
not only Vioxx but also with Celebrex.
Both the FDA and Merck have advised
patients taking Vioxx to consult their physician about
alternative medications.
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