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Revised Labeling for Cisapride
JAMA. 2000;283:1131.
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The FDA has revised the labeling of cisapride (Propulsid; Janssen Pharmaceutica, Titusville, NJ) and advised physicians to perform electrocardiography and measure serum electrolytes prior to prescribing the drug, which is used to treat severe nighttime heartburn. The recommendation is based on an analysis of 270 reports of serious cardiac arrhythmias (resulting in 70 deaths), about 85% of which occurred in patients taking cisapride and other drugs or who were at increased risk.
Cisapride 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 or promethazine); Class IA and Class III antiarrhythmics (such as quinidine, procainamide, and sotalol); tricyclic antidepressants (such as amitriptyline); certain antidepressants (such as nefazodone and maprotiline); certain antipsychotic medications (such as sertindole); and other agents (such as bepridil, sparfloxacin, and grapefruit juice).
Cisapride also . . . [Full Text of this Article]
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