Important Product and Safety Information
Cardiovascular Risk
- CELEBREX may cause an increased risk of serious cardiovascular thrombotic events,
myocardial infarction, and stroke, which can be fatal. All NSAIDs may have a similar
risk. This risk may increase with duration of use. Patients with cardiovascular
disease or risk factors for cardiovascular disease may be at greater risk.
- CELEBREX is contraindicated for the treatment of peri-operative pain in coronary
artery bypass graft (CABG) surgery.
Gastrointestinal Risk
- NSAIDs, including CELEBREX, cause an increased risk of serious gastrointestinal
adverse events including bleeding, ulceration, and perforation of the stomach or
intestines, which can be fatal. These events can occur at any time during use and
without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal
(GI) events.
CELEBREX is indicated for the relief of the signs and symptoms of osteoarthritis,
rheumatoid arthritis in adults, and ankylosing spondylitis, and for the management
of acute pain in adults.
CELEBREX is contraindicated for the treatment of perioperative pain in coronary
artery bypass graft surgery; in patients who have demonstrated allergic-type reactions
to sulfonamides; or in patients who have experienced asthma, urticaria, or allergic-type
reactions after taking aspirin or other NSAIDs.
Use the lowest effective dose for the shortest duration consistent with individual
patient treatment goals.
As with all NSAIDs, CELEBREX can lead to the onset of new hypertension or worsening
of pre-existing hypertension, either of which may contribute to the increased incidence
of CV events. Blood pressure should be monitored closely with all NSAIDs.
Fluid retention and edema have been observed in some patients taking NSAIDs, including
CELEBREX. NSAIDs should be used with caution in patients with fluid retention or
heart failure.
NSAIDs, including CELEBREX, may diminish the antihypertensive effect of angiotensin
converting enzyme (ACE) inhibitors and angiotensin II antagonists, and in some patients
can reduce the natriuretic effect of furosemide and thiazides.
CELEBREX can be used with low-dose aspirin. There is no consistent evidence that
concurrent use of aspirin mitigates the increased risk of serious CV thrombotic
events associated with NSAID use.
Concomitant administration of aspirin with CELEBREX increases the rate of GI ulceration
or other complications, compared with use of CELEBREX alone.
Treatment with NSAIDs, including CELEBREX, is not recommended in those patients
with advanced renal disease. In addition, NSAIDs may cause renal toxicity.
Serious skin reactions such as exfoliative dermatitis, Stevens Johnson syndrome,
and toxic epidermal necrolysis have been reported in patients receiving CELEBREX.
These reactions can be fatal. They can occur without warning and in patients without
prior known sulfa allergy. CELEBREX should be discontinued at the first appearance
of skin rash, mucosal lesions, or any other sign of hypersensitivity.
CELEBREX should be avoided in late pregnancy.
NSAIDs, including CELEBREX, should be used only with caution in patients with systemic
onset JRA, due to the risk of disseminated intravascular coagulation.
Serious bleeding events, some of which were fatal, have been reported in patients
receiving CELEBREX concurrently with warfarin.