PEAPACK, NJ — June 7, 2002 —
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® (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.
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