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SafetyAlerts
March 23, 2000

Reports 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 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 a limited-access protocol.

Notice of this product warning was sent via email to SafeMail subscribers March 23, 2000.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.