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Pfizer Claims Celebrex Safety in September:
Day Vioxx Recalled
Dec. 17, 2004 On September 30, the day Merck &
Co. announced the recall of its COX-2 drug, Vioxx, Pfizer issued a news
release expressing confidence that Celebrex did not cause heart
problems, as found in the case of Vioxx.
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"Pfizer is confident in the long-term
cardiovascular safety of Celebrex," said Dr. Joe Feczko, Pfizer's
president of worldwide development.
Following is the rest of the Pfizer statement on
Celebrex and their second COX-2 drug, Bextra:
Over 27 million patients in the United States have
been prescribed Celebrex (celecoxib), which was approved by the U.S.
Food and Drug Administration in 1998.
In a recent FDA-sponsored study of 1.4 million
patients, those who received Celebrex demonstrated no increased risk of
cardiac events.
"Patients taking COX-2 inhibitors may be confused
and should speak with their doctors," Dr. Feczko said. "Because of its
outstanding long-term safety profile and broad indication base including
osteoarthritis, rheumatoid arthritis and acute pain, Celebrex is an
appropriate treatment alternative."
Celebrex was the first COX-2 inhibitor, a class of
medicine designed to relieve pain without the serious gastrointestinal
side effects associated with older non-steroidal anti-inflammatory
medicines. In 2001, Pfizer introduced Bextra (valdecoxib), its second
COX-2 inhibitor, for use in osteoarthritis and rheumatoid arthritis.
Bextras cardiovascular safety profile is also well established in
long-term studies.
Data show that since the introduction of COX-2
inhibitors, the rate of hospitalizations for gastrointestinal events
associated with long-term arthritis treatment has declined
significantly.
Important safety information
You
should not take BEXTRA or CELEBREX if you've had allergic reactions to
certain drugs called sulfonamides, aspirin or other arthritis medicines
if you've had aspirin sensitive asthma, or are in late pregnancy.
BEXTRA is
not recommended if you have advanced kidney disease. Tell your doctor if
you have fluid retention problems. Be sure to tell your doctor if you
are pregnant, or if you have kidney or liver problems.
In rare
cases, serious stomach problems such as bleeding can occur without
warning. Tell your doctor right away if you develop blisters in the
mouth or a rash while taking BEXTRA, as it can be a sign of a serious
skin reaction that may be life threatening. If you experience other
unusual symptoms while taking BEXTRA or CELEBREX, tell your doctor
immediately.
In
clinical trials, the most common side effects with BEXTRA were headache,
abdominal pain, indigestion, upper respiratory infection, nausea and
diarrhea. The most common side effects in clinical trials with CELEBREX
were indigestion, diarrhea and abdominal pain.
End of company statement
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