Cisapride and Fatal Arrhythmia

Abstract

From September 1993, the month in which the marketing of cisapride (Propulsid, Janssen Pharmaceutica, Titusville, N.J.) began, to April 1996, the Food and Drug Administration's MedWatch reporting program (telephone number, 1-800-FDA-1088) received reports of 34 patients in whom torsade de pointes developed and 23 in whom prolonged QT intervals developed while using this drug. Four were reported to have died, and 16 responded to resuscitation after cardiopulmonary arrest. Arrhythmia was often preceded by syncopal episodes. Seven of the patients were children, and one was an adolescent.