US Food and Drug Administration
FDA Talk Paper: Janssen Pharmaceutica stops marketing cisapride
in the US
FDA Talk Paper
(Mar) T00:3/23/2000, 2000
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
JANSSEN PHARMACEUTICA STOPS MARKETING CISAPRIDE IN THE
Janssen Pharmaceutica Inc., of Titusville, N.J., has announced that
it has decided to stop marketing cisapride (Propulsid) in the United
States as of July 14, 2000. 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
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
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.
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