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United States Food and Drug Administration

FDA strengthening warning label for propulsid (cisapride)

FDA Talk Paper (Jun) T98:no.39 1998

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FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.


T98-39                          Print Media:         301-827-6242
June 29, 1998                   Broadcast Media:    301-827-3434
                                Consumer Inquiries: 800-532-4440

FDA STRENGTHENS WARNING LABEL FOR PROPULSID

FDA is advising doctors about new warnings of cardiac problems associated with the drug Propulsid (cisapride), a treatment for nighttime heartburn. FDA's warning is being issued in conjunction with a "Dear Healthcare Professionals letter" from the drug's sponsor, Janssen Pharmaceutica of Titusville, NJ. The drug's labeling has been revised to include new information about the cardiac risks associated with the drug and to recommend that other therapies for heartburn generally be used before Propulsid.

These actions were prompted by reports of serious adverse reactions -- including heart rhythm disorders and deaths associated mostly with the use of the drug in people who were taking certain other medications or who had particular underlying medical conditions. From 1993 to 1998 there were 38 reports of deaths in the U.S. Nevertheless, FDA cannot directly link reported deaths to the drug.

The "Dear Healthcare Professionals letter" and revised labeling for Propulsid emphasize that the drug should not be used in patients taking certain antibiotics, antidepressants, antifungals, protease inhibitors, or various other drugs. The strengthened warnings also contraindicate the drug's use in patients with certain disorders--such as congestive heart failure, multiple organ failure, chronic obstructive pulmonary disease which causes serious respiratory problems, and advanced cancer. Propulsid should also not be administered to patients with electrolyte disorders (hypokalemia or hypomagnesemia). These include patients with severe dehydration, vomiting, diarrhea, or malnutrition, or those taking potassium-wasting diuretics and/or insulin in acute settings, or who might experience rapid reduction of plasma potassium.

Furthermore, because of the risks associated with the drug and the many factors that need to be considered when properly administering it, doctors are being advised that Propulsid should usually be used in patients who have not responded adequately to lifestyle modifications or other drugs for treating nighttime heartburn due to gastroesophageal reflux disease.

Propulsid's current labeling states that the drug's use should be discontinued if relief from nighttime heartburn does not occur. The labeling further specifies that the minimum effective dose should be used and recommended doses should not be exceeded. It is also recommended that the daily dose be halved in patients with reduced liver function.

Propulsid was approved by the FDA in tablet form in 1993, and in suspension form in 1995 after 23 months of review. Health care providers should report any adverse events related to Propulsid to Janssen Pharmaceutica (800-526-7736) or to FDA. Reports may be submitted to FDA by telephone (800-332-1088), by fax (800-332-0178), or by mail using a postage paid MedWatch form from the back of the Physicians Desk Reference. The MedWatch report should be mailed to:

MedWatch (HF-2)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

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