United States of America - The manufacturer of cisapride has announced that it will stop marketing the product (Propulsid®: Janssen) in the USA with effect 14 July 2000. This effective date is intended to provide adequate time for patients and physicians to decide on treatment alternatives. Cisapride is a prescription drug indicated for severe night-time heartburn in patients with gastro-oesophageal reflux disease who do not adequately respond to other therapies.
Patients who already take the drug are encouraged to consult their doctors about other treatment options. The company will continue to make the drug available only to patients who meet specific clinical eligibility criteria under a limited-access protocol.
Continuing reports of heart rhythm disorders and deaths have been associated with cisapride in people taking certain other medications or with underlying conditions known to be risk factors. A recent analysis of 270 cases of adverse events (including 70 fatalities) revealed that approximately 85% of these cases occurred in patients with identifiable risks.
Reference: FDA Talk Paper, T00-14, 23 March 2000.