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IMPORTANT SAFETY INFORMATION

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:

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