# E-DRUG: Cisapride - New Safety Information **URL:** \ **Category:** e-drug\ **Created:** [June 9, 1999, 2:02pm UTC](https://talk.edrugplus.org/t/e-drug-cisapride-new-safety-information/5252 "1999-06-09T14:02:04Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![srahmad](https://avatars.discourse-cdn.com/v4/letter/s/e56c9b/32.png) [@srahmad](https://talk.edrugplus.org/u/srahmad)\ **Post date:** [June 9, 1999, 2:02pm UTC](https://talk.edrugplus.org/t/e-drug-cisapride-new-safety-information/5252/1 "1999-06-09T14:02:04Z")
E-DRUG: Cisapride - New Safety Information ------------------------------------------ News from U.S. Food and Drug Administration Janssen has sent out a June 1, 1999 letter on Propulsid (cisapride) to notify health professionals of two new contraindications (known family history of congenital long QT syndrome and clinically significant bradycardia) and a new drug interaction (coadministration of grapefruit juice with cisapride increases the bioavailablity of cisaparide and concomitant use should be avoided). [Editorial note: Cisapride is a heartburn medication. In the U.S. cisapride is "indicated for the symptomatic treatment of adult patients with nocturnal heartburn due to gastroesophageal reflux disease. Because of the risk of serious, and sometimes fatal, ventricular arrhythmias, PROPULSID should generally be reserved for patients who do not respond adequately to lifestyle modications, antacids and gastric acid reducing agents." (modified from PDR 1999 p.1430) Syed Rizwanuddin Ahmad] The company letter is reproduced below: IMPORTANT SAFETY INFORMATION June 1, 1999 Dear Doctor, Janssen Pharmaceutics would like to inform you of labeling changes concerning new CONTRAINDICATIONS and DRUG INTERACTIONS with PROPULISID (cisapride) We wish to draw your attention to the following sections of the revised PROPULSID labeling which contains the essential changes. Underlined words denote newly added information. Similar revisions have been incorporated into the PROPULSID Medication Guide. BOXED WARNING AND CONTRAINDICATIONS Two new medical conditions have added to the Contraindications and Boxed Warning sections of PROPULSID labeling. These include known family history of congenital long QT syndrome and clinically significant bradycardia. The purpose of these additions is to further clarify the contraindicated medical conditions for PROPULSID. These conditions are independent risk factors for QT prolongation. DRUG INTERACTIONS According to the Drug Interaction section of PROPULSID labeling: Coadministration of grapefruit juice with cisapride increases the bioavailabilty of cisapride and concomitant use should be avoided. This addition is based on the results of a drug interaction study conducted in normal volunteers, which demonstrated that the coadministration of grapefruit juice and cisapride resulted in an increased bioavailability of cisapride. As always, Janssen is committed to the safe and appropriate use of its products. Therefore, we at Janssen want you to be aware of this important information to ensure the proper use of PROPULSID in your patients. Please refer to the enclosed revised packaged insert for full prescribing information, including boxed warning and enclosed medication guide. The medical community can further our understanding of adverse events by reporting all cases to Janssen at 1-800-JANSSEN (526-7736) or to the FDA MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD, 20857. For additional medical information, please call 1-800-JANSSEN (526-7736) from 8AM to 8PM Eastern Time, Monday through Friday. Sincerely, Mark A. Klausner, MD Vice President Drug Safety and Epidemiology Janssen At Washington Crossing 1125 Trenton-Harbourton Road Post Office Box 200 Titusville, New Jersey 08560-0200, USA -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. Mail administrative requests to `majordomo@usa.healthnet.org'. For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.