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.
T00-6 Print Media: 301-827-6242
January 24, 2000
Consumer Media: 800-INFO-FDA
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 be discussed.
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 identifiable risks.
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 www.fda.gov/medwatch/ or by mail to:
MedWatch (HF-2)