Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T00-14 Print Media: 301-827-6242 March 23, 2000 Broadcast Media: 301-827-3434 Consumer Inquiries: 888-INFO-FDA
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.
As of December 31, 1999, use of cisapride 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.
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.
Since the drug’s approval in 1993, Cisapride’s labeling has been revised several times (most recently in January 2000, see FDA Talk Paper T00-6) to inform health care professionals and patients about the drug’s risks. Despite these risk management efforts, the firm decided in consultation with the Food and Drug Administration that continued general US prescription access to the drug poses unacceptable risks.
A public advisory committee meeting, previously scheduled for April 12 to discuss ways to reduce the occurrence of adverse events associated with cisapride, has been cancelled.
FDA News Page |   FDA Home Page
Office of Public Affairs
Hypertext uploaded by tg 2000-MAR-23.