---

Celebrex Trial Halted After Heart Attacks


Celebrex Trial Halted After Heart Attacks -- Posted by Roman Bystrianyk on 12-17-04 08:57


http://www.healthsentinel.com/news.php?event=news_print_list_item&id=476

"Celebrex Trial Halted After Heart Attacks", Reuters UK, December 17,
2004,
Link:
http://www.reuters.co.uk/newsArticle.jhtml;jsessionid=RFCKBYLM1PYWECRBAEZSFFA?type=healthNews&storyID=7126735

A government-sponsored trial of Pfizer Inc.'s blockbuster arthritis
drug Celebrex was halted after patients taking the medicine had more
than twice as many heart attacks as patients taking a placebo, the
company said on Friday.

Shares of Pfizer, a component of the Dow Jones industrial average, fell
17 percent in early trading following news of the long-term trial,
sponsored by the National Cancer Institute.

The heart-attack findings for Celebrex come only 10 weeks following
Merck & Co.'s recall of its similar arthritis drug, Vioxx, after a
study found the drug doubled the incidence of heart attack and stroke
among patients taking it to prevent colon polyps that cause cancer.
Both drugs are from a class known as COX-2 inhibitors.

"This does not bode well for COX-2 inhibitors in general," said Ira
Loss, an analyst at Washington Analysis. "The sense had been that
Celebrex is somehow different from the others."

A Pfizer spokesman declined to say if the company was considering
pulling Celebrex off the market.

Pfizer said the trial involved patients taking 400-milligram and
800-milligram daily doses of Celebrex to prevent adenomas, tumors that
grow from glandular tissue. The anti-inflammatory drug was being tested
on the theory that inflammation is a cause of cancer.

Officials of the U.S. Food and Drug Administration were not immediately
available for comment.

Vioxx and Celebrex both work by selectively blocking a protein called
COX-2 that has been linked to inflammation. They were both launched in
1999 and quickly became top-selling drugs, helped by massive television
and print advertising.

Pfizer also said on Friday that Celebrex was not shown to increase
heart risk in a second long-term trial designed to see if the drug
could prevent colon polyps.

The New York-based drugmaker said National Cancer Institute officials
decided to halt the other Celebrex trial, to test its ability to
prevent adenomas, after confirming "an approximately 2.5-fold increase
in their risk of experiencing a major fatal or non-fatal cardiovascular
event compared to those taking placebo."

"They (the NCI) will continue to follow patients in the study," said
Pfizer spokesman Paul Fitzhenry, although patients will no longer be
given Celebrex.

"We alerted the Food and Drug Administration last night about the
findings," said Fitzhenry. He said he could not elaborate on those
discussions.

Asked if Pfizer was considering pulling Celebrex off the market in view
of the findings, Fitzhenry said, "We cannot comment beyond our earlier
statement," which did not discuss the possibility of withdrawing the
drug.


Re: Celebrex Trial Halted After Heart Attacks -- Posted by Rick on 12-17-04 08:59


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Spondyloarthropathies: Reactive Arthritis (Reiter's Syndrome), Ankylosing
Spondylitis, Psoriatic Arthritis, IBD, and all they may bring. Uveitis,
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RISG.ORG Current news supplement. Week 12-16-04
---------------------------------
Posted Friday, December 17, 2004 by Rick:

Celebrex Trial Stopped After Heart Attacks
Reuters, NY - 28 minutes ago
NEW YORK (Reuters) - A government-sponsored trial of Pfizer Inc.'s
blockbuster arthritis drug Celebrex was halted after patients taking the
medicine had more ...
(link:http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=7126619)
http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=7126619

Pfizer Statement On New Information Regarding Cardiovascular ...
mysan.de, Germany - 2 hours ago
... FirstCall/ -- Pfizer Inc said it received new information last night
about the cardiovascular safety of its COX-2 inhibitor Celebrex (celecoxib)
based on an ...
(link:http://www.mysan.de/international/article16230.html)
http://www.mysan.de/international/article16230.html

Pfizer Reports Heart Risk With Celebrex
NewsFactor Network, CA - 12 minutes ago
After finding that patients taking 400mg to 800mg of Celebrex daily were
found to have a 2.5 times greater risk of experiencing heart problems than
those who ...
(link:http://business.newsfactor.com/story.xhtml?story_title=Pfizer-Reports-Heart-Risk-With-Celebrex&story_id=112.3261776&category=business)
http://business.newsfactor.com/story.xhtml?story_title=Pfizer-Reports-Heart-Risk-With-Celebrex&story_id=112.3261776&category=business

Pfizer halts Celebrex sales in Turkey
Seattle Post Intelligencer, WA - Nov 24, 2004
said Wednesday it has temporarily halted sales of its pain reliever Celebrex
in Turkey because health authorities there sought to include very
restrictive ...
(link:http://seattlepi.nwsource.com/business/apbiz_story.asp?category=1310&slug=Pfizer
Celebrex)
http://seattlepi.nwsource.com/business/apbiz_story.asp?category=1310&slug=Pfizer
Celebrex

Study: Celebrex Safer Than Vioxx
CBS News - Dec 7, 2004
(AP) New research suggests that top-selling pain reliever Celebrex does not
carry the same heart attack risk as Vioxx, a ... "Vioxx and Celebrex look
different. ...
(link:http://www.cbsnews.com/stories/2004/12/07/health/main659540.shtml)
http://www.cbsnews.com/stories/2004/12/07/health/main659540.shtml


Pfizer: Celebrex Increases Risk of Heart Problems
NEW YORK - Pfizer Inc. (PFE) said Friday it found an increased risk of heart
problems with patients taking its painkiller Celebrex, a drug that is in the
same class as Merck's Vioxx, which was pulled from the market in September
because of safety concerns.
(link:http://www.foxnews.com/story/0,2933,141838,00.html)
http://www.foxnews.com/story/0,2933,141838,00.html


Rick Hahn
rick@risg.org
http://www.risg.org

"Roman Bystrianyk" wrote in message
news:1103302660.105182.66630@z14g2000cwz.googlegroups.com...
> http://www.healthsentinel.com/news.php?event=news_print_list_item&id=476
>
> "Celebrex Trial Halted After Heart Attacks", Reuters UK, December 17,

> 2004,
> Link:
> http://www.reuters.co.uk/newsArticle.jhtml;jsessionid=RFCKBYLM1PYWECRBAEZSFFA?type=healthNews&storyID=7126735
>
> A government-sponsored trial of Pfizer Inc.'s blockbuster arthritis

> drug Celebrex was halted after patients taking the medicine had more
> than twice as many heart attacks as patients taking a placebo, the
> company said on Friday.
>
> Shares of Pfizer, a component of the Dow Jones industrial average, fell

> 17 percent in early trading following news of the long-term trial,
> sponsored by the National Cancer Institute.
>
> The heart-attack findings for Celebrex come only 10 weeks following

> Merck & Co.'s recall of its similar arthritis drug, Vioxx, after a
> study found the drug doubled the incidence of heart attack and stroke
> among patients taking it to prevent colon polyps that cause cancer.
> Both drugs are from a class known as COX-2 inhibitors.
>
> "This does not bode well for COX-2 inhibitors in general," said Ira

> Loss, an analyst at Washington Analysis. "The sense had been that
> Celebrex is somehow different from the others."
>
> A Pfizer spokesman declined to say if the company was considering

> pulling Celebrex off the market.
>
> Pfizer said the trial involved patients taking 400-milligram and

> 800-milligram daily doses of Celebrex to prevent adenomas, tumors that
> grow from glandular tissue. The anti-inflammatory drug was being tested
> on the theory that inflammation is a cause of cancer.
>
> Officials of the U.S. Food and Drug Administration were not immediately

> available for comment.
>
> Vioxx and Celebrex both work by selectively blocking a protein called

> COX-2 that has been linked to inflammation. They were both launched in
> 1999 and quickly became top-selling drugs, helped by massive television
> and print advertising.
>
> Pfizer also said on Friday that Celebrex was not shown to increase

> heart risk in a second long-term trial designed to see if the drug
> could prevent colon polyps.
>
> The New York-based drugmaker said National Cancer Institute officials

> decided to halt the other Celebrex trial, to test its ability to
> prevent adenomas, after confirming "an approximately 2.5-fold increase
> in their risk of experiencing a major fatal or non-fatal cardiovascular
> event compared to those taking placebo."
>
> "They (the NCI) will continue to follow patients in the study," said

> Pfizer spokesman Paul Fitzhenry, although patients will no longer be
> given Celebrex.
>
> "We alerted the Food and Drug Administration last night about the

> findings," said Fitzhenry. He said he could not elaborate on those
> discussions.
>
> Asked if Pfizer was considering pulling Celebrex off the market in view

> of the findings, Fitzhenry said, "We cannot comment beyond our earlier
> statement," which did not discuss the possibility of withdrawing the
> drug.
>




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