Propulsid

Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation have been reported in patients taking Propulsid®. From July 1993 through May 1999, more than 270 such cases have been spontaneously reported, including 70 fatalities. In approximately 85% of these cases the events occurred when Propulsid®was used in patients with known risk factors. These risk factors included the administration of other drugs which caused QT prolongation, inhibited the cytochrome P450 3A4 enzymes that metabolize cisapride, or depleted serum electrolytes; or the presence of disorders that may have predisposed patients to arrhythmias. In approximately 0.7% of these cases, the events occurred in the absence of identified risk factors; in the remaining cases, risk factor status was unknown. Because the cases were reported voluntarily from a population of unknown size, estimates of adverse event frequency cannot be made. (See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and Drug Interactions.)

Numerous drug classes and agents increase the risk of developing serious cardiac arrhythmias. Propulsid® is contraindicated in patients taking certain macrolide antibiotics (such as clarithromycin, erythromycin, and troleandomycin), certain antifungals (such as fluconazole, itraconazole, and ketoconazole), protease inhibitors (such as indinavir and ritonavir), phenothiazines (such as prochlorperazine and promethazine), Class IA and Class III antiarrhythmi...