Vioxx CV Precaution Mitigated By Data Showing Similar Placebo CV Risk
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Revised Vioxx (rofecoxib) labeling adding a cardiovascular precaution is tempered by the inclusion of data from two placebo-controlled studies finding no difference in the rates of CV thrombotic events between the Merck COX-2 inhibitor and placebo, the company suggested during an April 12 press conference.
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