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.
You may also be interested in...
Vioxx Label Balances CV Risk With GI Safety: Can Merck Reverse Damage?
The Vioxx labeling change will allow Merck to discuss the COX-2 inhibitor's cardiovascular safety profile in the context of a rheumatoid arthritis indication and a gastrointestinal safety benefit
Vioxx Label Balances CV Risk With GI Safety: Can Merck Reverse Damage?
The Vioxx labeling change will allow Merck to discuss the COX-2 inhibitor's cardiovascular safety profile in the context of a rheumatoid arthritis indication and a gastrointestinal safety benefit
Pharmacia To Publish Full 12-Month Data From CLASS Study Of Celebrex
Pharmacia is preparing to publish the full 12-month data from the Celebrex CLASS GI outcomes study.