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Propulsid
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On March 23, 2000, the US Food and Drug Administration (FDA) announced that
Janssen Pharmaceutica (a wholly-owned subsidiary of Johnson & Johnson) would
cease marketing of cisapride (Propulsid) in the United States as of July 14,
2000. In its announcement, the FDA stated that as of December 31, 1999, use
of cisapride has been associated with 341 reports of heart rhythm abnormalities
including 80 reports of deaths. Propulsid had been used as a treatment for severe
nighttime heartburn experienced by adult patients with gastroesophageal reflux
disease (GERD). Propulsid had been approved by the FDA in tablet form in 1993,
and in suspension form in 1995.
A variety of lawsuits have been filed against Janssen Pharmaceutica and Johnson
& Johnson over the effects of Propulsid.
- Propulsid Product Liability
Litigation (MDL-1355) Web Site, US District Court, Eastern District of
Louisiana
- Ruling Favors
Propulsid Maker, The Clarion-Ledger, September 30, 2001
- Infant Death Tied
to Lax Review of Propulsid, WebMD, April 27, 2000
- Popular Heartburn
Drug Continues to Cause Deaths, WebMD, April 13, 2000
- Letter
to the Food and Drug Administration Asking for the Immediate Withdrawal of
Propulsid from the Market, Public Citizen, Health Research Group, April
11, 2000
- Heartburn Drug
Withdrawn, WebMD, March 23, 2000
- Limited-Access Program
Announced in United States to Ensure Appropriate Use of Propulsid® (Cisapride):
Product No Longer To Be Promoted in United States, Johnson & Johnson,
March 23, 2000
- Janssen Pharmaceutica
Stops Marketing Cisapride in the US, US Food and Drug Administration,
March 23, 2000
- Heartburn
Drug Warning, ABCNews.com, January 24, 2000
- FDA Updates
Warnings for Cisapride, US Food and Drug Administration, January 24, 2000
- New
Warning for Heartburn Drug Propulsid, CNN.com, June 30, 1998
- FDA Strengthens
Warning Label for Propulsid, US Food and Drug Administration, June 29,
1998
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