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Pfizer Suspends Celebrex Ads - U.S. FDA
Pfizer Suspends Celebrex Ads - U.S. FDA -- Posted by Roman Bystrianyk on 12-20-04 05:12
http://www.healthsentinel.com/news.php?event=news_print_list_item&id=485
"Pfizer Suspends Celebrex Ads - U.S. FDA", Reuters UK, December 20,
2004,
Link:
http://www.reuters.co.uk/newsArticle.jhtml;jsessionid=3IGRHORR5EZJGCRBAEKSFFA?type=healthNews&storyID=7134595
Pfizer Inc. has agreed to suspend its advertisements for arthritis drug
Celebrex while U.S. regulators review new data that link the drug to an
elevated risk of heart attacks, a Food and Drug Administration
spokeswoman said on Sunday.
The FDA asked the drug giant on Friday night to temporarily cease the
Celebrex ads, and the company agreed, FDA spokeswoman Kathleen Quinn
said. Celebrex has been heavily promoted in television commercials and
magazine ads, helping propel sales of the drug to nearly $2 billion
last year.
The FDA also is working with Pfizer "to develop appropriate information
for physicians" about the new findings, Quinn said.
Pfizer could not immediately be reached for comment on Sunday night.
Earlier Sunday, Pfizer Chief Executive Hank McKinnell said doctors
should be made aware of the health risks in prescribing Celebrex to
their patients, but the company did not plan to recall the popular
arthritis drug.
"We're leaving Celebrex on the market because it is an appropriate
option for many, many patients," McKinnell said on ABC's "This Week."
"Physicians do need to be fully advised of the risks and particularly
this new information."
On Friday, Pfizer said Celebrex more than doubled the risk of heart
attack in a large cancer-prevention trial, a setback that came just
weeks after Merck & Co. recalled its similar Vioxx drug due to heart
safety risks.
The FDA on Friday urged doctors to consider prescribing alternatives to
Celebrex. The agency said it was leaving all regulatory options open
and would have more announcements about Celebrex in the next few days.
Dr. David Graham, associate director for science in the FDA's Office of
Drug Safety, criticized the agency for failing to protect the public
from dangerous drugs.
"The FDA, I believe, is more concerned with getting drugs on to the
market than it is in getting safe drugs on to the market," Graham said
on the same television program.
Merck recalled Vioxx on Sept. 30 after a study found that a long-term
use of the drug doubled the risk of heart attack and stroke. Both
Celebrex and Vioxx belong to a class of drugs known as COX-2
inhibitors. They work by selectively blocking a protein called COX-2
that has been linked to inflammation.
The FDA said on Friday it had serious concerns about the whole range of
COX-2 inhibitors, which includes another Pfizer drug called Bextra.
Pfizer said the Celebrex trial, sponsored by the National Cancer
Institute, involved patients taking 400-milligram and 800-milligram
daily doses of the drug to prevent tumors known as adenomas that grow
from glandular tissue. High doses of the anti-inflammatory drug were
being tested on the theory that inflammation is a cause of cancer.
Celebrex is one of Pfizer's biggest products, with 2003 sales of $1.9
billion.
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