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FDA is advising doctors about new warnings of cardiac problems associated with the drug Propulsid (cisapride), a treatment for nighttime heartburn. FDA's warning is being issued in conjunction with a "Dear Healthcare Professionals letter" from the drug's sponsor, Janssen Pharmaceutica of Titusville, NJ. The drug's labeling has been revised to include new information about the cardiac risks associated with the drug and to recommend that other therapies for heartburn generally be used before Propulsid.
These actions were prompted by reports of serious adverse reactions -- including heart rhythm disorders and deaths associated mostly with the use of the drug in people who were taking certain other medications or who had particular underlying medical conditions. From 1993 to 1998 there were 38 reports of deaths in the U.S. Nevertheless, FDA cannot directly link reported deaths to the drug.

The "Dear Healthcare Professionals letter" and revised labeling for Propulsid emphasize that the drug should not be used in patients taking certain antibiotics, antidepressants, antifungals, protease inhibitors, or various other drugs. The strengthened warnings also contraindicate the drug's use in patients with certain disorders--such as congestive heart failure, multiple organ failure, chronic obstructive pulmonary disease which causes serious respiratory problems, and advanced cancer. Propulsid should also not be administered to patients with electrolyte disorders (hypokalemia or hypomagnesemia). These include patients with severe dehydration, vomiting, diarrhea, or malnutrition, or those taking potassium-wasting diuretics and/or insulin in acute settings, or who might experience rapid reduction of plasma potassium.

Furthermore, because of the risks associated with the drug and the many factors that need to be considered when properly administering it, doctors are being advised that Propulsid should usually be used in patients who have not responded adequately to lifestyle modifications or other drugs for treating nighttime heartburn due to gastroesophageal reflux disease.

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