Propulsid warnings issued

Janssen Pharmaceutica has agreed to a Food and Drug Administration proposal to issue warning labels limiting the dosage and use of its heartburn drug Propulsid (cisapride) based on reports of cardiac arrhythmia when the drug is taken in a combination regimen.

The warnings advise that only patients with diagnosed gastroesophageal reflux disease who are not responding to other therapies be given Propulsid (vs. patients with more mild heartburn), and that the lowest effective dosage should be determined and administered. Also included is a warning that the drug should be discontinued if nocturnal heartburn is not relieved.

The warnings were determined following reports of arrhythmia in patients taking the drug along with cytochrome isoenzyme inhibitors or other drugs newly found to cause interactions. Propulsid has been contraindicated for use with P-450 3A4 inhibitors.n