propulisid

Propulsid was a prescription drug designed for the treatment of
severe gastroesophageal reflux disease (GERD), a disorder more
commonly known as acute nighttime heartburn. Propulsid, the
brand name for the chemical cisapride, was prescribed in both
tablet and liquid form for use in cases of adult heartburn and
pediatric colic. To date, there have been over 30 million Propulsid
prescriptions written for some 10 million patients.

After Propulsid’s approval in 1993, there were several revisions
to the Propulsid label, informing health care professionals and
patients about various side effects and risks, the most serious of
which involved cardiac irregularities. Although Propulsid was only
associated with mild adverse effects upon approval, the drug was
soon linked to life-threatening heart rhythm abnormalities
(arrhythmias) and cardiac arrest in people with no prior heart
disease.

After years of escalating fatalities linked with Propulsid and
pressure from the FDA, Janssen Pharmaceutical Inc., a division of
Johnson & Johnson, announced that it would voluntarily stop
marketing Propulsid in the United States beginning July 14, 2000.

Presently, Propulsid has been linked to 386 reports of heart
rhythm abnormalities, including 125 deaths. All of the deaths
involved ventricular arrhythmias, non-specified arrhythmias, cardiac
arrest or sudden death. Symptoms include heart palpitations, rapid
heartbeat, chest pain and fatigue. A simple EKG can be used to
diagnose a potential problem associated with these conditions
(frequently undetected prior to a serious heart attack).



	Propulisid Information