Contraindicated Use of Cisapride

Abstract

Cisapride is a gastrointestinal tract promotility agent that was first marketed in the United States in August 1993 with a label indication for nocturnal heartburn.¹ Use grew rapidly so that in 1995 there were approximately 5 million outpatient cisapride prescriptions filled in the United States.² However, by this time, the Food and Drug Administration (FDA) had received 34 cases of torsade de pointes and 23 of prolonged QT interval in cisapride users, including 4 deaths.³ Since many of these cases were in patients taking drugs that inhibited the cytochrome P450-3A4 enzymes that metabolize cisapride,¹ a "black-box" warning was added to the cisapride label in 1995 contraindicating use in patients taking drugs that affected cisapride metabolism and the manufacturer sent a "Dear Health Care Professional" letter. In April 1996, more information on the cases was published.³ The second report also suggested that use of cisapride could be hazardous in patients taking medications that prolonged the QT interval or with chronic diseases that predisposed to cardiac arrhythmias.