In Brief: Wyeth-Ayerst/Interneuron Redux
Executive Summary
Wyeth-Ayerst/Interneuron Redux: Dexfenfluramine will carry a box warning in labeling discussing the association of valvular heart disease with concomitant use of fenfluramine and phentermine. FDA issued a health advisory warning about the association July 8 ("The Pink Sheet" July 14, p. 4). The box warning also will contain information from current labeling on the risk of primary pulmonary hypertension, which "has symptoms similar to those of cardiac valvular disease," Wyeth says...
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Wyeth-Ayerst/Interneuron Redux: Dexfenfluramine will carry a box warning in labeling discussing the association of valvular heart disease with concomitant use of fenfluramine and phentermine. FDA issued a health advisory warning about the association July 8 ("The Pink Sheet" July 14, p. 4). The box warning also will contain information from current labeling on the risk of primary pulmonary hypertension, which "has symptoms similar to those of cardiac valvular disease," Wyeth says.... |