Reports of Heart Problems and Deaths Move Janssen Pharmaceutica Inc. to Stop the Sale of Propulsid
March 23, 2000
Titusville, NJ (SafetyAlerts) - In the wake of numerous reports that indicate some patients who take Propulsid are experiencing heart rhythm abnormalities, Janssen Pharmaceutica Inc. has decided to stop marketing the heartburn medicine in the United States as of July 14, 2000.
As of December 31, 1999, use of cisapride (Propulsid) has been associated with 341 reports of heart rhythm abnormalities including 80 reports of deaths. Most of these adverse events occurred in patients who were taking other medications or suffering from underlying conditions known to increase risk of cardiac arrhythmia associated with cisapride.
The effective date of the voluntary action is intended to provide adequate time for patients and physicians to make alternative treatment decisions.
Cisapride is a prescription drug treatment approved only for severe nighttime heartburn experienced by adult patients with gastroesophageal reflux disease (GERD) that does not adequately respond to other therapies.
Patients who are currently prescribed cisapride are urged to promptly contact their health care providers to discuss alternative treatments.
Physicians who are treating patients with severely debilitating conditions
for whom they believe the benefits of the cisapride may still outweigh
its risks are encouraged to contact Janssen at 1-800-JANSSEN. The company
will continue to make the drug available to patients who meet specific
clinical eligibility criteria for limited-access protocol.