-----Original Message-----
From: ME/CFS and Fibromyalgia Information Exchange Forum
[mailto:[log in to unmask]] On Behalf Of Melissa O'Toole
Sent: Friday, December 17, 2004 14:26
To: [log in to unmask]
Subject: [CFS-FM_INFO] NOT,MED: Pfizer Finds Celebrex Heart Attack Risk
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Sender: ME/CFS and Fibromyalgia Information Exchange Forum
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Poster: Melissa O'Toole <[log in to unmask]>
Subject: NOT,MED: Pfizer Finds Celebrex Heart Attack Risk
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[This may be of interest, given that many ME/CFS patients
in the US have been prescribed Celebrex as an alternative
to NSAUDs for pain relief.]
Pfizer Finds Celebrex Heart Attack Risk
December 17, 2004
By THERESA AGOVINO, AP Business Writer
NEW YORK - Pfizer Inc. said it has found an increased risk of heart
attacks with patients taking its top-selling painkiller Celebrex, a drug
that is in the same class as Vioxx, but has no plans to remove it from
the market.
Pfizer announced Friday that it found the increased risk in one of two
long-term cancer prevention trials, while the other trial showed no
increased risk.
The National Cancer Institute (news - web sites), which was conducting
the study for Pfizer, suspended the use of Celebrex after discovering
that patients taking 400mg to 800mg of the drug daily had a 2.5 times
greater risk of experiencing major heart problems than those who were
not. A separate cancer study found no increased heart risk with patients
taking 400mg of Celebrex per day.
Pfizer was conducting the trials as part of an effort to find a new
application for the drug.
The stock of the world's largest pharmaceutical maker plunged in morning
trading on the New York Stock Exchange (news - web sites), losing 14.6
percent, or $4.22, at $24.76 in heavy volume.
Both Celebrex and Vioxx, which is made by Merck & Co., are a type of
drug called cox-2 inhibitors, which have become popular because of their
effectiveness in treating the pain of arthritis and other ailments.
Vioxx was pulled from the market in September because of safety
concerns.
Dr. Marie Griffin, an epidemiologist and drug safety expert at
Vanderbilt University, said the new findings on Celebrex is worrisome
evidence suggesting that all these cox-2 drugs have similar risks.
However, she noted that the halted study was testing an 400 to 800
milligram dose - four times the usual dose - and that the safety problem
with Celebrex may only apply to those high levels.
"What this means for people who have heart disease is it's best to avoid
these drugs," she said.
For others, "people may want to reconsider their use of coxibs until we
feel better about their safety," and if they are using them, stick to
the normal dose, Griffin said.
Dr. Richard Hayes, a cardiologist in New York, said he would be
recommending that his patients taking Celebrex switch to nonprescription
medicines such as Advil to treat their pain.
"We thought Celebrex was safe and the problem was just with Vioxx,"
Hayes said. "The problem is more complex than we thought."
Celebrex is the most-prescribed drug for treating arthritis. In the nine
months ending in September, worldwide sales of Celebrex more than
doubled from the same period a year earlier to $2.29 billion, accounting
for 6 percent of Pfizer's total sales of $37.59 billion.
In releasing news of the study's findings, Pfizer chairman Henry
McKinnell said in a statement the company wanted to "rapidly communicate
new information to regulators, physicians and patients around the
world."
The withdrawal of Vioxx has been a financial and public relations
disaster for Merck, in part because it has been accused of muzzling news
about the drug's side effects. Its legal liabilities are estimated at up
to $18 billion, and its shares have dropped by nearly one-third since
the recall announcement was made in late September.
Vioxx had been a blockbuster drug for Merck, it's No. 2 earner with
annual global sales of $2.5 billion, amounting to 11 percent of the
company's $22.49 billion in revenue last year. Some 2 million people
worldwide had been taking Vioxx.
Dr. Joseph Feczko, president of worldwide development for Pfizer, noted
that the results in the trial finding increased risk of heart attacks
were not consistent with either the other cancer prevention trial or
with a "large body of data" that the company had collected.
Earlier this month, the Food and Drug Administration (news - web sites)
said it was adding a warning to the labels of another Pfizer drug,
Bextra, noting a risk of potential heart problems associated with the
use of Bextra in people who have recently had heart bypass surgery.
Bextra is also a cox-2 inhibitor type of drug.
Griffin and two other Vanderbilt epidemiologists also raised fresh
concerns about Bextra, Pfizer's other cox-2, in a letter to be published
Thursday in the New England Journal of Medicine (news - web sites).
Doctors should not prescribe the drug "except in extraordinary
circumstances," they recommend.
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