Janssen Pharmaceutica will stop
marketing the prescription heartburn drug Propulsid (cisapride) in the United
States as of July 14, 2000.
A Food and Drug Administration (FDA) statement issued Thursday notes that
the drug has been associated with 341 reports of heart rhythm abnormalities
including 80 reports of deaths.
"Most of these adverse events occurred in patients who were taking other
medications or suffering from underlying conditions known to increase risk of
cardiac arrhythmia associated with cisapride," according to the FDA.
The move to withdraw the drug is voluntary and the effective date is
intended to provide time for patients and physicians to make treatment
decisions. Patients who are currently prescribed Propulsid are urged to promptly
contact their healthcare providers to discuss alternatives.
The drug is used to treat severe nighttime heartburn in adult patients with
gastroesophageal reflux disease (GERD) that does not adequately respond to other
therapies. Its labeling has been revised several times since it was approved in
1993, to point out its risks.
"Despite these risk management efforts, the firm decided in consultation
with the Food and Drug Administration that continued general US prescription
access to the drug poses unacceptable risks," note FDA officials.
The FDA advises physicians who are treating patients with severely
debilitating conditions for whom they believe the benefits of cisapride outweigh
its risks to contact Janssen. The Titusville, New Jersey company will continue
to make the drug available to patients who meet specific clinical eligibility
criteria for a limited-access protocol.
In light of the decision to withdraw the drug, the FDA has canceled a public
advisory meeting scheduled for April 12, in which ways to reduce adverse effects
associated with Propulsid were to be discussed.
