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CLASS Study: The estimated cumulative rates at 9 months of complicated and symptomatic ulcers (an adverse event similar but not identical to the “upper GI ulcers, gross bleeding or perforation” described in the preceding paragraphs) for patients treated with CELEBREX 400 mg BID (see Special Studies - Use with Aspirin) are described in Table 5. Table 5 also displays results for patients less than or greater than or equal to the age of 65 years. The differences in rates between CELEBREX alone and CELEBREX with ASA groups may be due to the higher risk for GI events in ASA users. Table 5
Complicated and Symptomatic Ulcer Rates in Patients Taking CELEBREX 400 mg BID (Kaplan-Meier Rates at 9 months [%]) Based on Risk Factors
Complicated and Symptomatic
Ulcer Rates
All Patients
Celebrex alone (n=3105) 0.78
Celebrexwith ASA (n=882) 2.19
Patients <65 Years
Celebrex alone (n=2025) 0.47
Celebrexwith ASA (n=403) 1.26
Patients 65 Years
Celebrexalone (n=1080) 1.40
Celebrexwith ASA (n=479) 3.06
In a small number of patients with a history of ulcer disease, the complicated and symptomatic ulcer rates in patients taking CELEBREX alone or CELEBREX with ASA were, respectively, 2.56% (n=243) and 6.85% (n=91) at 48 weeks. These results are to be expected in patients with a prior history of ulcer disease (see WARNINGS - Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation). Text Continues Below
Anaphylactoid Reactions As with NSAIDs in general, anaphylactoid reactions have occurred in patients without known prior exposure to CELEBREX. In post-marketing experience, rare cases of anaphylactic reactions and angioedema have been reported in patients receiving CELEBREX. CELEBREX should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS - Preexisting Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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