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Silver Lining For Pfizer? Celebrex Well-Positioned In NSAID Class

This article was originally published in The Pink Sheet Daily

Executive Summary

The boxed warning for Pfizer's Celebrex will differ only slightly from labeling for other prescription NSAIDs, FDA says. All products will bear new language addressing increased cardiovascular and gastrointestinal risks. The agency appears open to renewed direct-to-consumer advertising for Celebrex.

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Celebrex Has Lower Risk Of Death Than Vioxx Or NSAIDs In CHF Patients, Study Says

The study in the British Medical Journal finds risk of death and recurrent congestive heart failure higher in patients on Vioxx or NSAIDs than Celebrex. A second study in the same issue finds "significantly increased" risk of myocardial infarction in patients using Vioxx, diclofenac or ibuprofen, but not Celebrex or naproxen.

Celebrex Has Lower Risk Of Death Than Vioxx Or NSAIDs In CHF Patients, Study Says

The study in the British Medical Journal finds risk of death and recurrent congestive heart failure higher in patients on Vioxx or NSAIDs than Celebrex. A second study in the same issue finds "significantly increased" risk of myocardial infarction in patients using Vioxx, diclofenac or ibuprofen, but not Celebrex or naproxen.

Bextra Relaunch Plan Could Include Weekly Monitoring, Pfizer CEO Says

Pfizer is focusing on finalizing Celebrex relabeling and safety study, but plans to turn attention to Bextra "once the dust settles," McKinnell says. Potential risk management plan for the COX-2 inhibitor could include weekly doctor's visits to monitor skin rash risk during first month of treatment.

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