March 23, 2000Reports of Heart Problems and
Deaths Move Janssen Pharmaceutica Inc. to Stop the Sale of Propulsid
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
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
Patients who are currently prescribed cisapride
are urged to promptly contact their health care providers to discuss alternative
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 a limited-access protocol.
Notice of this product warning was sent via email
to SafeMail subscribers March 23,
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