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PEAPACK, N.J., June 7 /PRNewswire-FirstCall/ -- Pharmacia Corporation and Pfizer Inc today announce that after a comprehensive review of the Celecoxib Long-term Arthritis Safety Study (CLASS) data, the U. S. Food and Drug Administration (FDA) has approved revised labeling for CELEBREX(R) (celecoxib capsules). This prospective, long-term safety outcomes study was designed to evaluate gastrointestinal (GI) safety of CELEBREX at supra therapeutic doses for osteoarthritis (OA) and rheumatoid arthritis (RA) compared to common therapeutic doses of diclofenac and ibuprofen. The study also provided new information about cardiovascular (CV) safety, hypertension, edema and hematologic events.
New label reaffirms the GI and CV safety profile of CELEBREX
Specifically, the new prescribing information includes additional GI safety data from CLASS. Importantly, the revised label also includes data indicating that there was no increased risk for serious CV adverse events observed compared to the non-specific NSAID comparators (diclofenac and ibuprofen). These CV events included heart attack, stroke and unstable angina.
The revised label includes data through nine months of treatment. This timepoint was the median duration of exposure for CELEBREX and diclofenac groups and there were no new safety signals beyond this timepoint.
Upper GI Safety Profile
Upper GI ulcers, gross bleeding or perforation are adverse events similar to, but not identical to, complicated and symptomatic ulcers. The primary endpoint of CLASS was the incidence of complicated ulcers -- gastrointestinal bleeding, perforation or obstruction. Differences in the incidence of complicated ulcers between CELEBREX and the combined group of non-specific NSAID comparators were not statistically significant. One possible explanation may be due to confounding factors such as premature discontinuation of non-specific NSAID patients and concurrent aspirin use, a risk factor for GI events.
Labeling for prescription NSAIDs show an annual rate of upper GI ulcer, gross bleeding or perforations of about 2-4% in patients treated for one year. The new label reflects nine-month data from CLASS showing that the estimated cumulative incidence of upper gastrointestinal (GI) complicated and symptomatic ulcers for CELEBREX is 0.78% even at doses higher than FDA approved doses of CELEBREX for osteoarthritis (OA) and rheumatoid arthritis (RA) respectively. Estimated cumulative incidence of upper GI complicated...