Correspondence
Cisapride and Fatal Arrhythmia
N Engl J Med 1996; 335:290-291July 25, 1996
- Article
To the Editor:
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.
Thirty-two of the 57 patients (56 percent) were also taking medications of the imidazole class (ketoconazole, fluconazole, itraconazole, and metronidazole) or macrolide antibiotics (erythromycin and clarithromycin), which have been found to inhibit the cytochrome P-450 3A4 enzyme system that affects cisapride metabolism and results in increased serum cisapride levels.1,2
There were temporal associations between the onset of arrhythmia and the initiation of cisapride, an increase in the dose, or the addition of an imidazole antifungal agent or macrolide antibiotic. For most patients, arrhythmia stopped after the discontinuation of cisapride or the imidazole or macrolide antibiotic (or both). In 9 of the 15 patients tested, serum cisapride levels were higher than the mean maximal levels found in clinical studies, although 2 patients with normal serum levels had recently undergone hemodialysis. Torsade de pointes and prolongation of the QT interval recurred in two patients who were rechallenged with cisapride and one rechallenged with ketoconazole. Other factors that may have increased the risk of arrhythmia in the 57 patients included histories of coronary disease and arrhythmia (predominantly atrial fibrillation) in 22 (39 percent), renal insufficiency or renal failure in 14 (25 percent), electrolyte imbalance in 11 (19 percent), and long-term use of medications associated with arrhythmia or prolonged QT intervals (such as amiodarone and phenothiazines) in 7 (12 percent).
The development of torsade de pointes and prolonged QT intervals in cisapride users appears to be associated with conditions that affect the metabolism of the drug. These include the concomitant use of medications that are metabolized by the cytochrome P-450 3A4 isozyme, the presence of renal insufficiency, and the administration of high doses of cisapride.3 Also, because there is some evidence that cisapride may be arrhythmogenic,4,5 users with histories of arrhythmia and cardiac disease may have an increased risk, beyond that conferred by their disease, of prolonged QT intervals and torsade de pointes.
As stated by the manufacturer in two letters1,2 addressed to physicians in the United States in 1995 and in a boxed warning recently added to the cisapride product-information label, physicians should avoid prescribing cisapride to patients who are taking ketoconazole, fluconazole, itraconazole, miconazole, erythromycin, clarithromycin, or troleandomycin. In addition, caution should be exercised when prescribing cisapride to patients who are taking medications known to prolong the QT interval and to those with renal insufficiency, a history of arrhythmia, and cardiac disease.
5 ReferencesDiane K. Wysowski, Ph.D.
Janos Bacsanyi, M.D.
Food and Drug Administration, Rockville, MD 208571
Klausner MA, Janssen Pharmaceutica Research Foundation. Dear Doctor letters. February 3, 1995, October 14, 1995.
2
Ahmad SR ,Wolfe SM . Cisapride and torsades de pointes. Lancet 1995;345:508-508
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Bran S ,Murray WA ,Hirsch IB ,Palmer JP . Long QT syndrome during high-dose cisapride. Arch Intern Med 1995;155:765-768
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Olsson S ,Edwards IR . Tachycardia during cisapride treatment. BMJ 1992;305:748-749
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Kaumann AJ . Do human atrial 5-HT4 receptors mediate arrhythmias? Trends Pharmacol Sci 1994;15:451-455
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