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In March 2000, Jansen
Pharmaceutica, a subsidiary of Johnson & Johnson
voluntarily halted the marketing of Propulsid (cisapride)
because of reports of heart rhythm abnormalities and death.
The FDA approved Propulsid in
1993. Propulsid was used to treat severe nighttime heartburn
in patients with gastroesophageal reflux disease (GERD) who
did not respond well to other treatments. GERD is the backward
flow of stomach contents to the esophagus. Some doctors also
prescribed it to infants. In 1999, Propulsid's worldwide sales
were approximately $950 million.
From 1993 until January 2000,
Propulsid's label was revised five times to warn doctors and
patients against the risks of taking the drug. The FDA
reported in March 2000 that 381 cases of heart rhythm
abnormalities and 80 deaths were recorded.
On the federal level, a
multi-district litigation center (MDL) has been set up in New
Orleans to handle lawsuits filed against Jansen Pharmaceutica
and Johnson and Johnson. A federal judge has been appointed to
preside over the vast amount of discovery that will take place
between the Plaintiff's Steering Committee and the defendants.
Propulsid FAQs
What is Propulsid?
What does the FDA now say
about the drug?
What types of cardiac
problems have been reported?
Did all users of Propulsid
experience problems?
Is Propulsid used for
children?
Are some people at higher risk
than others?
Is Propulsid still in use?
What legal recourse do
Propulsid users have, if any?
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