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FDA/Kaiser Study Revises Cardiovascular Risk For Merck's Vioxx

This article was originally published in The Pink Sheet Daily

Executive Summary

The study, led by FDA Office of Drug Safety official Graham, shows a 1.34 relative risk for Vioxx compared to remote NSAID use after data were revised to "correctly apply enrollment criteria for cases and controls." The study was not powered to detect an effect for Vioxx based on duration of use.

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