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Pfizer Cardura

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Additional data from NIH's ALLHAT study is needed before any changes are made to labeling for Pfizer's antihypertensive doxazosin, FDA's Cardiovascular and Renal Drugs Advisory Committee recommends at its May 24 meeting. The group met to discuss whether labeling should reflect preliminary data from the study, which suggests Cardura patients were twice as likely as the control group to be hospitalized for congestive heart failure. The CHF risk was 8.1% for the doxazosin patients and 4.5% for the chlorthalidone patients. The doxazosin arm of the study was halted in January 2000 based on a low probability of demonstrating superior efficacy to chlorthalidone and a higher rate of CHF

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