“Arthritis drugs Vioxx, Celebrex safety in doubt”
In doubt and may not be as safe as previously thought. Research
earlier this year has shown that these drugs increased the risk
of heart attacks although a relatively low risk, over those
taking a pain reliever. The FDA is debating whether to add
information about the increased risk on both drugs’ labels. One
Wall Street analyst has warned that this problem could have an
adverse effect on Merck, the drug company responsible for these
drugs be placed on the market - along with Pharmacia, which
makes Celebrex, generating $2.3 billion in 12 months to March 31
of this year, Merck having sold $1.7 billion Vioxx during the
same 12 months.
Studies done last year showed that patients taking Vioxx had
four times the risk of heart attacks over patients taking
Naproxen - another pain reliever. Naproxen is also sold under
the brands names of Naprosyn and Aleve. The risk of heart
attacks increases over time, at about four heart attacks per
1,000 patients. This study was sponsored by the Merck company,
which also stated that their research does not show this problem
of increased heart attacks with Vioxx.
These two drugs are among the best-sellers of prescription drugs
in the world. They cause fewer ulcers that many other drugs
given for pain. Richard R. Stover, a pharmaceutical industry
analyst at Arnhold & S. Bleichroeder Inc, reported on April 27
that he did his own analysis on what he called “disturbing data”
from Merck’s study. He stated that he was warning his clients,
many of whom were institutional investors holding stock in
Merck, that they should watch the issue carefully because it
could effect the company’s stock price. Dr. M. Michael Wolfe,
chief of the gastroenterology section at the Boston University
School of Medicine and a member of the FDA advisory committee
stated that there should be a warning, after a review of the
issue earlier this year, stating that “The marketing of these
drugs is unbelievable, I’m sure there are many people out there
who are taking these drugs that should not be.”
There is a current debate going on between some doctors and
Merck’s scientists as to whether the higher risk of heart
attacks is a result of Vioxx causing damage in some patients or
to an absence of the benefits that Naproxen may have in
protecting the heart, that Naproxen stops or slows the
production of thromboxane, which is thought to cause platelet in
the blood to form clots, similar to the aspirin effect.
Vioxx and Celebrex have been shown to have the same benefit in
protecting the heart.
Several doctors say they are worried about the possibility of
heart attacks because many of the arthritis patients taking the
drugs are elderly and have a higher risk of cardiovascular
problems to begin with. The current debate centers on whether
the higher heart attack rate found in patients taking Vioxx is a
result of the drug’s actually causing damage in some patients or
to an absence of the heart-protecting benefits that Naproxen may
have.
“Naproxen had a similar anti-platelet effect to aspirin,” said
Dr. Eve E. Slater, senior vice president of external policy for
Merck’s research labs, “and those people had fewer heart
attacks.”
Neither Vioxx nor Celebrex has been shown to have the same
heart-protecting benefit.
Slater also said that Stover’s report was flawed and biased in
favor of Pharmacia. But regulators and some doctors say they
still worry that there may be more of a problem with Vioxx. And
even if Vioxx and Celebrex do not damage the heart, the fact
that they do not have the heart-protecting benefits of aspirin
reduces the ability of the companies to market them as being
significantly safer than other pain relievers. Merck recommended
last year that doctors involved in clinical trials of Vioxx
consider prescribing low doses of aspirin to patients taking
Vioxx if they are at high risk of heart attacks - although low
doses of aspirin could increase the risk of ulcers. Ulcers are
the main side effect that Vioxx and Celebrex were developed to
avoid.
There have been no studies done to determine whether patients
have fewer ulcers if they take low doses of aspirin with either
Vioxx or Celebrex. In February Dr Maria Lourdes Villalba, at an
FDA advisory meeting, stated that Merck had proved Vioxx
[Rofecoxib] caused fewer serious ulcers than Naproxen. However,
she also state that the potential safety advantage was offset by
a higher risk of heart problems,in her opinion. She reported
that “Overall, there was no safety superiority of Rofecoxib over
Naproxen, mainly due to an excess of serious cardiovascular
events”.
Dr Villalba also stated that there had been no studies to prove
Merck’s claim that Naproxen worked like aspirin in decreasing
heart attacks. The FDA expressed some concern over the higher
rate of heart attacks with Vioxx, stating that this could be
caused by the drug’s ability to produce blood clots.
“There is still a tremendous benefit with these drugs” reported
Dr Eve Slater of Merck.
About the author:
Margot B, Writer, Web Developer Margot B has written a book and
hundreds of articles, specializing in health and the environment.
mailto:margotb@wonderport.com Web Sites by Margot B:
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