Propulsid® (cisapride) is manufactured by Janssen Pharmaceutica, a wholly owned subsidiary of Johson & Johnson.  It is a treatment for severe nighttime heartburn and acid reflux disease but it is not an antacid.  An antacid works by reducing the amount of acid in the stomach; Propulsid works by preventing food and stomach acid from entering the esophagus.  This is accomplished by causing the constriction of the muscles between the esophagus and the stomach.  The drug was approved by the FDA in 1993 despite safety concerns and risks of detrimental effects on the heart.  Propulsid was removed from the United States market on July 14, 2000.

Propulsid® was removed from the market because of safety-related concerns.  However, it is estimated that 30 million Americans were exposed to Propulsid during the time that it was marketed.  According to the FDA, between 1993 and 1999, the use of cisapride was responsible for 341 reports of heart rhythm abnormalities and up to 80 deaths.  To date, Propulsid has been cited in at least 300 deaths and over 400 reports of heart rhythm abnormalities.  Heart rhythm abnormalities include irregular beating and pumping of the heart, which can be fatal if sufficiently severe.  Many children dies because the medication was not properly prescribed and parents/patients were not properly warned about the dangers of Propulsid.

A major concern with the use of Propulsid® is the fact that the medication was not widely studied in pregnant women, meaning that there was little data regarding fetal impacts at the time Propulsid was in use.  However, extrapolation from animal studies that linked harm to the fetus indicates a great potential for fetal harm.  Because of this, and the fact that cisapride has been shown to be present in breast milk, it is certain that nursing infants were exposed.  This can result in unintended harm to children.  Propulsid has also been shown to be more dangerous to the elderly.

Propulsid use may cause or exacerbate many health-related conditions and/or symptoms:

If you need assistance with a Propulsid®-related injury please contact us.

NAME	DESCRIPTION
Janssen Pharmaceutica	US site of the manufacturer of Propulsid®.  Janssen is a wholly owned subsidiary of Johnson & Johnson.
Propulsid® Product Site	Information about Propulsidfrom  Janssen.
Food and Drug Administration	U.S. Food and Drug Administration. (FDA)
Why Drugs Get Pulled of the Market?	FDA article on why drugs are withdrawn from the market.
Propulsid Information from the FDA	Searchable database from the FDA.
FDA Strengthens Warning Label for Propulsid	FDA Warning from June 29, 1998.
FDA Updates Propulsid Warnings	FDA Updates Warnings for Cisapride - January 24, 2000.
FDA Notice about Propulsid Use in the United States	Janssen Pharmaceutica stops marketing cisapride in the US - from the FDA Center for Drug Evaluation and Research (CDER).
Medline from the National Institutes of Health (NIH)	Medline is provided by the National Institutes of Health, National Library of Medicine
Information on Propulsid from Medline (Locate on List)	Information from Medline about Propulsid.
Propulsid    MedMaster - Cisapride    USP DI - Cisapride (Systemic)	Information from Medline about Propulsid.
InteliHealth -    More Propulsid Information	Searchable directory from InteliHealth, an Aetna Company.
Propulsid Product Liability Litigation (MDL-1355) Web Site	Information on Propulsid Lawsuits from the US District Court, Eastern District of Louisiana
Infant Death Tied to Lax Review of Propulsid	Article from WebMD about infant death and Propulsid use - April 27, 2000.
Popular Heartburn Drug Continues to Cause Deaths	Article from WebMD about deaths related to Propulsid use, WebMD, April 13, 2000
Heartburn Drug Withdrawn	Article from WebMD about the withdrawal of Propulsid from the U.S. market - March 23, 2000.