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).
