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News From the Food and Drug Administration
March 1, 2000

Revised Labeling for Cisapride

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JAMA. 2000;283(9):1131. doi:10.1001/jama.283.9.1131-JFD00001-2-1

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.