U.S. Food and Drug Administation
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April 12, 2000
Dear Healthcare Provider,
Janssen Pharmaceutica would like to inform you of important changes regarding Propulsid (cisapride) Tablets and Suspension. Because of the risk of serious cardiac arrhythmias and death associated with the use of Propulsid in certain patients, Janssen, in consultation with the FDA, has decided to discontinue marketing Propulsid as of July 14, 2000 and make it available only through an investigational limited access program. Propulsid has been associated with serious cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation. From July 1993 through December 1999, 341 such cases have been spontaneously reported, including 80 deaths. In approximately 85% of these cases the events occurred when Propulsid was used in patients with known risk factors.
Over the past few years, Janssen has implemented labeling changes and sponsored educational programs to help assure the safe and appropriate use of Propulsid. However, the level of adverse event reporting and risks associated with the drug did not sufficiently decrease. Consequently, Janssen has decided to stop marketing the drug and make it available only through an investigational limited access program. Physicians should discuss with patients their current medical condition and the option of stopping Propulsid and, if needed, the possible use of alternative therapies (such as lifestyle modifications and/or use of acid reducing agents).
For patients who fail other treatment options and who meet clearly defined eligibility criteria, Janssen is establishing an investigational limited access program. Enrollment in the investigational limited access program will begin May 1, 2000. Janssen will market the product until July 14, 2000, and the product will remain available through pharmacies until approximately mid-August 2000. Between now and July 14, 2000, physicians should reassess the need for Propulsid in each patient given the risks of the drug and available alternatives.
The following are the three treatment protocols for the investigational limited access program:
In order for patients to be enrolled in the program they must have failed all standard therapeutic modalities and have undergone an appropriate diagnostic evaluation, including radiologic examinations or endoscopy. In addition, physicians must perform baseline screening tests, including laboratory tests and ECG to screen for contraindicated risk factors. A physician evaluation, laboratory tests, and ECG must be repeated at regular intervals according to the protocol.
The prescribing physician participating in the limited access program must be board eligible or certified in one or more of the following areas: internal medicine (including gastroenterology and cardiology), family practice, pediatrics (including neonatology) or surgery. The patient must also be under the care of a gastroenterologist by consultation, if the prescribing physician is not a gastroenterologist. Since the above protocols reflect investigational uses of Propulsid, institutional review board approval, completion of a Form FDA 1572, and signed informed consent are required.
Janssen, in consultation with the FDA, is currently finalizing all program materials. Physicians interested in enrolling patients or obtaining further information regarding the investigational limited access program should call toll-free 1-877-795-4247 beginning May 1, 2000.
All serious adverse events related to Propulsid's use must be reported to Janssen at 1-800-JANSSEN (526-7736) or to the FDA MedWatch Program by phone 1-800-FDA-1088, by fax 1-800-FDA-0178, by mail (using postage-paid form) MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or via www.FDA.gov/medwatch.
Please refer to the enclosed package insert for full prescribing information, including Boxed Warning. Please note that the package insert has not been revised and is enclosed for your reference and use over the next few months. For additional medical information concerning Propulsid, please call Janssen at 1-800-JANSSEN (526-7736) from 9 AM to 5 PM Eastern Time, Monday through Friday.
Jan Gheuens, MD, PhD
Vice President, Medical Affairs
Janssen Pharmaceutica Products, L.P. 2000
1125 Trenton-Harbourton Road
Titusville, New Jersey 08560
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