January 24, 2000FDA Releases Important Safety Information Concerning the Heartburn
Medicine Cisapride (Propulsid)
Washington, DC (SafetyAlerts) - The Food and Drug
Administration (FDA) is advising health care professionals and patients of important new
information, including recommendations for performing diagnostic tests, that should be
considered prior to any use of the drug cisapride (Propulsid).
Cisapride is a treatment for severe nighttime
heartburn in patients with gastroesophageal reflux disease (GERD) who do not adequately
respond to other therapies. The new measures are being recommended to help physicians
avoid giving cisapride to patients at known risk of rare-- but serious--cardiac events
associated with the drug.
As part of an ongoing risk management effort, FDA
is also announcing a public advisory committee meeting to be held on April 12, where the
safety of the drug and additional methods to reduce the occurrence of adverse events will
Meantime, patients who already take the drug are
encouraged to ask their doctors about having the recommended tests performed and whether
they should pursue other treatment options.
Today's actions are prompted by continuing reports
of heart rhythm disorders and deaths associated mostly with the use of the drug in people
who are either taking certain other medications or who have certain underlying conditions
that are known risk factors. A recent analysis of 270 adverse event reports (including 70
fatalities) revealed that approximately 85% of these cases occurred in patients with these
The new risk management measures are being
announced in conjunction with a "Dear Healthcare Professionals" letter issued
today by the drug's sponsor, Janssen Pharmaceutica of Titusville, NJ, that summarizes the
updates being made to the warnings and precautions sections of the drug's label. The
changes include recommending that physicians perform an electrocardiogram and certain
blood tests prior to prescribing the drug.
The revised labels also list the contraindicated
drugs and underlying conditions which put patients at increased risk. Cisapride should not
be used by patients taking some of the following types of medications: anti-allergy,
anti-angina, anti-arrhythmics (irregular heart rhythm), antibiotics, anti-depressants,
anti-fungals, anti-nausea, anti-psychotics and protease inhibitors (anti-HIV infection).
It is also advised that patients with any of the
following conditions not take the drug: history of irregular heartbeats, abnormal
electrocardiogram (ECG or EKG), heart disease, kidney disease, lung disease, low blood
levels of potassium, calcium or magnesium, eating disorder (such as bulimia or anorexia),
dehydration or persistent vomiting.
Cisapride was approved by FDA in tablet form in
1993, and in suspension form in 1995. Unlike drugs that reduce stomach acid, cisapride
works by a prokinetic mechanism that moves the harmful acids through the digestive tract
thus preventing its painful reflux into the esophagus. A previous warning regarding
cardiac risks was issued in June 1998 (see FDA Talk Paper T98-39).
Healthcare providers are encouraged to report any
adverse events related to cisapride to Janssen Pharmaceutica (800-526-7736) or the FDA.
Reports may be submitted to FDA by telephone (800-FDA-1088), fax (800-FDA-0178), online at