ABOUT
CELEBREX
An estimated 27 million Americans have
taken Celebrex to relieve chronic pain
from arthritis, menstrual cramps or
other conditions. But recent studies
have found that patients who take this
non-steroidal anti-inflammatory drug (NSAID)
- like Vioxx and Bextra - have a higher
risk of heart attacks, strokes and
internal bleeding.
Celebrex is Pfizer's brand of celecoxib,
a non-steroidal anti-inflammatory drug
(NSAID) used to relieve chronic pain.
In December 2004, the Food and Drug
Administration (FDA) issued an advisory
noting that Celebrex may be associated
with an increased risk of serious
cardiovascular events (heart attack and
stroke) especially when used for long
periods of time or in very high risk
settings, such as immediately after
heart surgery.
In April 2005, the FDA asked Pfizer to
take the following actions:
-
Revise the Celebrex label to include a
boxed warning about cardiovascular and
gastrointestinal bleeding risks, plus
specific information on the controlled
clinical trial data that demonstrate an
increased risk of adverse CV events for
celecoxib.
-
Encourage prescribers to discuss with
patients the potential benefits and
risks of Celebrex and other treatment
options before a decision is made to
use Celebrex.
-
Encourage practitioners to use the
lowest effective dose for the shortest
duration consistent with individual
patient treatment goals.
-
Include a Medication Guide as part of
the labeling.
-
Commit to conduct a long-term study to
address the safety of Celebrex compared
to naproxen and other appropriate
drugs. FDA will work with Pfizer to
design this long-term study and ensure
its timely initiation and completion.
Looking for a CELEBREX lawyer? Call us
toll-free at any time, 24 hours a day,
at 1-888-890-HURT (4878) or
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