FDA Alerts related to Celebrex (Celecoxib)
FDA ALERT-[4/7/2005]: Celebrex has been linked
to an increased risk of serious cardiovascular (CV) events (such as
heart attack or stroke) which appears to be a risk shared by all
medicines called non-steroidal anti-inflammatory drugs (NSAIDs)
(excluding aspirin). FDA has requested that the package insert
(labeling) for all NSAIDs, including Celebrex, be revised to include
a “boxed” or serious warning to highlight the potential increased
risk of CV events, and the well known risk of serious, and
potentially life-threatening, stomach bleeding. FDA has also
requested that the package insert for all NSAIDs be revised to state
that patients who have just had heart surgery should not take these
medicines.
For complete, up-to-date safety information by the FDA, see MedWatch
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