E-DRUG: Cisapride - New Safety Information
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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
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