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.
You may also be interested in...
Arena Finds Antidote For Belviq’s Theoretical Risk Of Valvulopathy In Mechanistic Studies
Additional preclinical studies provided FDA with reassurance during a second-cycle review that lorcaserin was unlikely to trigger the valvular heart disease associated with dexfenfluramine and fenfluramine.
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.
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.