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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:
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| 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. |
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