Janssen to Stop Marketing Cisapride

As of July 14, 2000, Janssen Pharmaceutica Inc. (Titusville, NJ) will stop marketing cisapride (Propulsid), the company's prescription drug treatment for severe nighttime heartburn caused by gastroesophageal reflux disease (GERD), in the United States. Under a limited-access program developed by Janssen and the FDA, the drug will be available to appropriate patients for whom other therapies are not effective and who meet clearly defined eligibility criteria.

The decision was made in response to mounting evidence of adverse effects caused by the drug. As of December 31, 1999, use of cisapride was associated with 341 reports of heart rhythm abnormalities, including 80 reports of deaths. Most of these events occurred in patients who were taking other medications or suffering from underlying conditions known to increase risk of cardiac arrhythmia associated with cisapride.

Since the its approval in 1993, Cisapride's labeling has been revised several times to inform health care professionals and patients about the drug's risks. Despite these risk-management efforts, Janssen decided, in consultation with the FDA, that continued general U.S. prescription access to the drug poses unacceptable risks.

Patients who are currently prescribed cisapride should promptly contact their health care providers to discuss alternative treatments. Physicians who are treating patients with severely debilitating conditions for whom they believe the benefits of the cisapride may still outweigh its risks are encouraged to contact Janssen at 800-JANSSEN.

For more information: Food and Drug Administration, U.S. Department of Health and Human Services, Public Health Service, 5600 Fishers Lane, Rockville, MD 20857. Tel: 301-827-6242.

Edited by Jim Pomager