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COX-2 Class Labeling From Vioxx/Celebrex Data Proposed By FDA Consultant

Executive Summary

Class labeling for COX-2 inhibitors incorporating data from Pharmacia's Celebrex and Merck's Vioxx large-scale safety studies may be useful in explaining differential safety results in gastrointestinal and cardiovascular adverse events, a consultant to FDA's Arthritis Advisory Committee suggested Feb. 8.
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