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[e-drug] after Vioxx, now Bextra?

E-DRUG: after Vioxx, now Bextra?
--------------------------------
[from DRUGINFO (our South African 'me-too' E-drug)with thanks; Copied as fair 
use. WB]

Hi all

This NYT story (here as "fair use") shows how the bad news keeps
flowing - although the relevance to longer-term oral use is unclear,
there are data that show increased cardiovascular risk with valdecoxib
when used IV/po in bypass patients. Every efforts is being made to keep
the valdecoxib story from affecting celecoxib's standing ("Since the
Vioxx withdrawal, Pfizer has been emphatic in distancing its drugs from
Vioxx and playing down concerns about higher risk for heart attack and
stroke. The company says it is even conducting research into whether
Celebrex might reduce the risk of such events."), but the really telling
statement in this story is this one: [Dr. Kweder, from the FA] "noted
that neither Celebrex nor Bextra had been proved to be any better than
older medicines like ibuprofen at guarding against stomach bleeding, a
benefit often cited with these drugs, and neither had been proved to be
any better at relieving pain than older drugs". That's what should
inform policy and practice until longer-term safety data are available
from purpose-designed trials.

regards

Andy Gray MSc(Pharm) FPS
* Senior Lecturer, Dept of Experimental and Clinical Pharmacology
* Study Pharmacist, Centre for the AIDS Programme of Research in South Africa 
(CAPRISA)
Nelson R Mandela School of Medicine
University of KwaZulu-Natal
PBag 7 Congella 4013
South Africa
Tel: +27-31-2604334/4298 Fax: +27-31-2604338
email: graya1@ukzn.ac.za or andy@gray.za.net

~~~

http://www.nytimes.com/2004/10/16/business/16pfizer.html?oref=login&oref=login

Pfizer Warns of Risks From Its Painkiller
By REED ABELSON
Published: October 16, 2004

Pfizer warned doctors yesterday that one of its best-selling
painkillers, Bextra, might increase the risk of heart attack or stroke
in coronary artery bypass surgery patients. The announcement comes just
two weeks after Merck removed from the market its painkiller, Vioxx,
which is in the same class of medicines as Bextra, because a study
showed that the risk of heart attacks doubled for patients who had taken
Vioxx 18 months or longer. 

Pfizer said a clinical study involving more than 1,500 patients showed
that those who had undergone bypass surgery and had taken Bextra
intravenously and orally were at higher risk for heart attacks. An
initial study last year raised similar concerns in the same kinds of
patients. 

The painkillers known as COX-2 inhibitors, which include Bextra and
Vioxx, have been widely prescribed to people with arthritis. Merck's
decision to withdraw Vioxx cast suspicion on the safety of drugs in that
class. Now Pfizer's warning is sure to fuel the debate about the overall
safety of these drugs for all patients.

Officials of the Food and Drug Administration said yesterday that the
agency would convene a panel of independent experts in January to
discuss these issues. Regulators abroad have also indicated plans to
review COX-2 drugs.

Pfizer said it was already conducting research into whether Bextra
increases the risk of heart attacks in people taking the drug for
chronic pain. The company also issued a warning yesterday about an
extremely rare and potentially fatal skin reaction to Bextra.

In addition to Bextra, Pfizer also makes Celebrex, the best-selling
COX-2 drug on the market. Bextra is the company's new and faster-acting
version of Celebrex. 

Pfizer says there is no evidence that its drugs have problems similar
to Vioxx because they are chemically different. Although Bextra is not
approved for use for surgery patients, Pfizer said its studies had shown
that general surgery patients - as opposed to bypass patients - are not
at higher risk for heart attacks. 

But some doctors say this group of drugs may work in a way that
increases the risk of heart problems for some patients, and they point
to this latest information as additional reason for concern. 

"There are serious questions to be addressed here," said Dr. Garret A.
FitzGerald, a University of Pennsylvania cardiologist and pharmacologist
who raised concerns about the painkillers in The New England Journal of
Medicine this month. 

But Dr. FitzGerald also emphasized that these drugs are useful for
certain patients. "We absolutely shouldn't yank these drugs as a class,"
he said.

Other doctors also expressed concerns about the new information from
Pfizer. "It's going to require a lot of really serious looks," said Dr.
David Campen, a rheumatologist for Kaiser Permanente in California, a
major health network, who has also been involved in research on some of
these drugs.

Millions of people have taken these drugs for pain and chronic
conditions like rheumatoid arthritis, and sales of these three drugs -
Vioxx, Celebrex and Bextra - exceeded $6 billion last year. 

Regulators in Europe are expected to make a decision as soon as next
week about whether to take any action on the drugs. The F.D.A.'s expert
panel will review whether Celebrex and Bextra are safe, Dr. Sandra
Kweder, acting director of the administration's office of new drugs,
said in an interview yesterday. 

While no study of either drug analyzed by the agency so far has been
cause for concern, Dr. Kweder said, the agency is not sure it has all
the information it needs. The agency is aware of the two studies
involving the intravenous form of Bextra, but "it's unclear what the
relationship is with the oral form," she said. 

Other recent studies suggesting that all COX-2 inhibitors may have
safety problems are still being analyzed by the agency, she said.
Uncertainty over the safety of drugs is not uncommon, Dr. Kweder said,
and that is "something we have to take into account with regard to every
decision we make about marketing a new drug and every decision we make
about withdrawal of a drug."

But some doctors say because the benefits of COX-2 drugs are so
unclear, the advantages of taking one of these painkillers may not
outweigh these risks.

"You have to treat people who are high risk conservatively," Dr. Campen
said.

The F.D.A. will take this into account, Dr. Kweder said. She also noted
that neither Celebrex nor Bextra had been proved to be any better than
older medicines like ibuprofen at guarding against stomach bleeding, a
benefit often cited with these drugs, and neither had been proved to be
any better at relieving pain than older drugs.

The agency will have to balance the risks and benefits of these drugs.
"That's what we're going to ask the advisory committee to do," she
said.

Since the Vioxx withdrawal, Pfizer has been emphatic in distancing its
drugs from Vioxx and playing down concerns about higher risk for heart
attack and stroke. The company says it is even conducting research into
whether Celebrex might reduce the risk of such events. 

Many doctors have said it is critical that research be conducted to
settle this issue. "It's a trial long overdue," said Dr. Eric J. Topol,
chairman of cardiovascular medicine at the department at the Cleveland
Clinic, who said the information about what happened in bypass patients
was "very worrisome."

Dr. FitzGerald criticized Pfizer for not making this latest information
public more quickly since the company had completed the study in the
spring. Pfizer said it could not have released this information earlier
because it had to analyze the information.

"I thought we took a rather extraordinary step," said Dr. Mitch
Gandelman, a Pfizer executive, who said the company released the
information before it normally would to quickly share it with
doctors.Pfizer officials emphasized that the news about Bextra does not
implicate Celebrex. 

Shares of Pfizer's fell 58 cents, to close at $28.50 yesterday,
although the shares had been down even more sharply earlier in the day.

Gardiner Harris contributed reporting for this article.



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