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FDA FENFLURAMINE/REDUX EPIDEMIOLOGICAL ANALYSIS OF HMO RECORDS SUPPORTS FINDINGS OF VALVULOPATHY IN ASYMPTOMATIC PATIENTS REPORTED FROM FIVE SURVEYS

Executive Summary

An FDA analysis of computerized patient records from an Oregon HMO provided one piece of evidence that convinced the agency to recommend that Wyeth-Ayerst withdraw Redux (dexfenfluramine) and Pondimin (fenfluramine) from the market.

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AHP Use Of Testing In Redux Follow-Ups Undermines Antimonitoring Stance

American Home Products' use of echocardiographic monitoring in follow-up studies in patients who received the diet drugs Pondimin (fenfluramine) or Redux (dexfenfluramine) argues for a medical monitoring program for individuals who took the drug but are still asymptomatic, plaintiffs in a N.J. class action suit contend.

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