Propulsid®, whose generic name is cisapride, is an anti-heartburn,
anti-gastric reflux medication that was marketed by Janssen Pharmaceutica
in this country beginning in 1993. It was removed from the marketplace
in the summer of 2000 following numerous reports of sudden death
in both the adult and pediatric populations.
Despite being
essentially a drug used to enhance gastric motility, or to promote
the emptying of the stomach contents into the intestine, the drug
was ultimately widely prescribed for gastro-esophageal reflux disease,
or GERD. As early as 1992, there were reports within the medical
literature of fast heart rates associated with Propulsid and, in
1995, Propulsid® was linked with a potentially deadly irregular
heart rate known as torsades de pointes.
By January of
2000, more than 270 cases of adverse cardiac events had been reported,
including 70 fatalities. Perhaps even more troubling was that for
approximately half the time the drug was on the market, more than
50 adverse events involving children or babies were reported to
the FDA. At this time, Propulsid® has been linked with the development
of Sudden Infant Death Syndrome (SIDS).
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