Celebrex

[celecoxib]

Gastrointestinal:

Intestinal obstruction, intestinal perforation, gastrointestinal bleeding, colitis with bleeding, esophageal perforation, pancreatitis, ileus

Liver and biliary system:

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Cholelithiasis, hepatitis, jaundice, liver failure Hemic and lymphatic:

Thrombocytopenia, agranulocytosis, aplastic anemia, pancytopenia, leukopenia

Metabolic:

Hypoglycemia, hyponatremia

Nervous system:

Aseptic meningitis, ataxia, suicide

Renal:

Acute renal failure, interstitial nephritis

Skin:

Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis

General:

Sepsis, sudden death, anaphylactoid reaction, angioedema

Safety Data from CLASS Study:
Hematological Events:

During this study (see Special Studies - Use with Aspirin), the incidence of clinically significant decreases in hemoglobin (>2 g/dL) confirmed by repeat testing was lower in patients on CELEBREX 400 mg BID (4-fold and 2-fold the recommended OA and RA doses, respectively, and the approved dose for FAP) compared to patients on either diclofenac 75 mg BID or ibuprofen 800 mg TID: 0.5%, 1.3% and 1.9%, respectively. The lower incidence of events with CELEBREX was maintained with or without ASA use (see CLINICAL STUDIES - Special Studies - Platelets).

Withdrawals/Serious Adverse Events:

Kaplan-Meier cumulative rates at 9 months for withdrawals due to adverse events for CELEBREX, diclofenac and ibuprofen were 24%, 29%, and 26%, respectively. Rates for serious adverse events (i.e. those causing hospitalization or felt to be life threatening or otherwise medically significant) regardless of causality were not different across treatment groups, respectively, 8%, 7%, and 8%.

Based on Kaplan-Meier cumulative rates for investigator-reported serious cardiovascular thromboembolic adverse events*, there were no differences between the CELEBREX, diclofenac, or ibuprofen treatment groups. The rates in all patients at 9 months for CELEBREX, diclofenac, and ibuprofen were 1.2%, 1.4%, and 1.1%, respectively. The rates for non-ASA users in each of the three treatment groups were less than 1%. The rates for myocardial infarction in each of the three non-ASA treatment groups were less than 0.2%.

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