Vioxx May Have Caused 140,000 Heart Attacks
Jan 26 '05
Food and Drug
Administration safety reviewer David Graham estimates that Merck's Vioxx may have caused as many as 140,000 heart attacks
in the U.S. before it was withdrawn last September. His estimate was published in the British medical journal Lancet.
The study was based on records of 1.4 million members of
Kaiser Permanente, the largest U.S. nonprofit insurer, with 6 million members in California. Many of the cases may have been
fatal, Graham said.
A Merck spokesman said the estimate of harm from Vioxx
was "speculation." Determinations of Vioxx's potential role in patients' cardiovascular problems "can only be made on a case
by case basis," he said.
The publication of Graham's findings is expected to intensify
the drug-safety debate that has swept Washington since the Vioxx withdrawal. Graham and other critics accuse the FDA of being
too slow to ban or tighten regulations on medicines that cause serious side effects.
Researchers compared the incidence of heart attacks and
sudden cardiac death for patients taking Vioxx with those on Pfizer's Celebrex, a similar painkiller, and over-the-counter
Applying the findings across the U.S. population, "We arrived
at the estimate of 88,000 to 140,000 patients that had a heart attack in the U.S. because they used Vioxx" after it was introduced
in 1999, Graham said.
Portions of the study had been disclosed earlier. Graham
said in Nov. 18 testimony before the Senate Finance Committee that between 88,000 and 139,000 heart attacks may have been
linked to Vioxx.
Merck withdrew Vioxx after a company study showed that
patients taking it for 18 months or longer had twice the risk of heart attacks and strokes -- 1.5 percent -- as those taking
Graham said his bosses at the FDA at one point threatened
to fire him as associate director for science and medicine in the agency's Office of Drug Safety if he published the findings.
The study found that Vioxx, given at the standard dose,
increases the risk of heart attack by about 50 percent, compared with Pfizer's Celebrex, and more than triples the risk of
heart attacks when given at high doses. The two drugs suppress the body's production of the Cox-2 enzyme, which is linked
to pain and swelling.
People taking Vioxx had a 34 percent higher chance of heart
disease compared with those taking other painkillers including Celebrex, naproxen and ibuprofen, the study found.
Patients taking naproxen, a generic painkiller sold as
Aleve by Bayer AG, had a 14 percent increase in heart risk compared with some other painkillers such as ibuprofen, the study
showed. Previous trials had suggested naproxen may protect against cardiac disease.
Copyright © 2003-2005 ConsumerAffairs.com Inc. All Rights Reserved.
Downfall of a Super drug VIOXX
AARP Bulletin 11/04
Though the news about Vioxx surprised many patients, debate about its heart safety began among
medical researchers not long after the drug hit the market. Cardiologists from
the Cleveland Clinc published an analysis in 2001 showing that the clinical trial that demonstrated Vioox’s ability
to lower chances of bleeding also revealed a fivefold increase in heart attacks among Vioxx versus Naproxen [However a study
of Naproxen was stopped after
three years when it was noticed that patients taking naproxen…. About 50% more such cardiovascular events in the Naproxen
arm of the study than in the placebo division, at http://healthfully.org/medicalcrap/id11.html. Thus the increase is more than 5-fold].
Several observationl studies reinforced the finding. But Merck argued
that Vioxx only appeared to promote heart attacks because, in comparison, protected against them.
In 2001 the FDA required Me4rck to add a warning of possible heart effects to the Vioxx label and cited the company
for minimizing the cardiovascular risks in some of its promotions. Among these
was a May 2001 press release headlined “Merck confirms Favorable Cardiovascular Safety Profile of Vioxx.” In its warning letter to Merck, the FDA called the claim “simply incomprehensible.”
Study of Celebrex, Naproxen
By PAUL RECER, AP Science Writer
- A study testing whether Celebrex or naproxen would reduce the risk of Alzheimer's disease (news - web sites) was halted Monday after researchers noted an increase in heart attack and stroke among participants who were taking naproxen,
an over-the-counter pain reliever on the market for nearly 30 years. Officials at the National Institutes of Health (news - web sites) said the study was stopped after three years when it was noticed that patients taking naproxen, sold under the brand name
Aleve, had a 50 percent greater incidence of cardiovascular events — heart attack or stroke — than patients taking
placebo. Another factor, officials said, was the announcement last week that advertising for Celebrex was being halted after
a study found that high doses of the drug was associated with an increase in heart attack risk. Data from the Alzheimer's
study, however, did not indicate an increased risk for heart attack or stroke.
and naproxen are both pain relievers commonly used to treat arthritis. Naproxen has been approved for sale, first as a prescription
and then as an over-the-counter drug, since 1976.
to obtain reaction Monday night produced no answers at phone numbers for Bayer Healthcare, the maker of Aleve, a popular version
of naproxen. Dr. Sandra Kweder of the Food and Drug Administration (news - web sites) said the NIH study is the first to show that naproxen might increase the risk of heart attack or stroke. "We agree that this is confusing," she said. The FDA (news - web sites) will closely evaluate the findings from the NIH study, said Kweder, but that no new regulatory action with naproxen is expected
within the next few days. She said patients who routinely take naproxen should
follow the drug directions carefully, including the instruction not to take it for more than 10 days, and to consult a doctor
if there continues to be pain. The Alzheimer's disease study was being conducted
by the National Institute on Aging, an arm of the NIH. It called for 2,500 patients, aged 70 or older and who had a family
history of Alzheimer's, to take either Celebrex, naproxen or placebo.
group was divided and each division, or arm, was assigned to receive one of the drugs or placebo. The drugs were blinded,
which means the patients did not know which medication they were taking. The
goal was to determine if the pain-relieving drugs lowered the risk of developing Alzheimer's disease. The study started three
years ago and was to continue for a few more years. Officials said the patients in the study will be monitored for developing
Alzheimer's, but will not be given the test drugs. Dr. Elias A. Zerhouni, the
director of the National Institutes of Health, said the study linking heart attack to Celebrex last week was a major factor
in deciding to suspend the Alzheimer's study. He said there was a question whether
patients in the study would continue to take their medicine since they knew they might be taking Celebrex.
the study, Zerhouni said, "is the prudent thing to do." John Breitner of
the Veterans Affairs medical facility in Seattle and the University of Washington, an investigator in the trial, said only
preliminary data is available. But he said it suggests that about 70 patients of the 2,500 suffered stroke or heart attack,
including 23 deaths, and that there were about 50 percent more such events in the naproxen arm of the study than in the placebo division.