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FDA Advisory Committee Confirms Safety, Efficacy of Cardura (Doxazosin Mesylate) For High Blood Pressure/Benign Prostatic Hyperplasia NEW YORK, NY -- May 25, 2001 -- Pfizer Inc said today that it is pleased that an FDA advisory panel affirmed that its alpha-blocker Cardura (doxazosin mesylate) is safe and effective as currently labeled for its indications of high blood pressure and benign prostatic hyperplasia. Pfizer said it will continue to work closely with the U.S. Food and Drug Administration and other regulatory agencies around the world as additional data from the ALLHAT trial becomes available to determine whether label additions are warranted. The advisory panel was reviewing data from a clinical trial sponsored by the National Institute of Health. In that trial, known as ALLHAT, preliminary results showed a lower incidence of congestive heart failure (CHF) in patients taking a diuretic, a commonly used treatment for CHF, for which Cardura is not indicated. In its presentation to the FDA panel, Pfizer said that a review of 316 Pfizer-sponsored clinical trials involving over 49,000 patients concluded that Cardura does not cause CHF. Further, neither Pfizer's own post-marketing database nor a review of 27 scientific articles that tracked nearly 6,000 patients showed evidence that Cardura is causally associated with CHF, heart attack or stroke. Cardura, which was approved in the United States in 1990, has accumulated over four billion patient days of experience. SOURCE: Pfizer Inc Related Links: Pfizer Inc and Cardura (doxazosin mesylate). E-mail this page to a friend or colleague! To print, use this version