Propulsid
Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation have been reported in patients taking Propulsid (cisapride). From July 1993 through May 1999, more than 270 such cases have been spontaneously reported, including 70 fatalities. In approximately 85% of these cases the events occurred when Propulsid was used in patients with known risk factors.
How does Propulsid work?
Unlike drugs that reduce stomach acid, cisapride works by a prokinetic mechanism that moves the harmful acids through the digestive tract thus preventing its painful reflux into the esophagus.
What are the Risk Factors associated with using Propulsid?
The risk factors include the administration of other drugs which cause QT prolongation, inhibit the cytochrome P450 3A4 enzymes that metabolize cisapride, or deplete serum electrolytes: or the presence of disorders that may have predisposed patients to arrhythmias.Who should NOT take Propulsid?
It is advised that patients with any of the following conditions
not take the drug:
- History of irregular heartbeats
- Abnormal electrocardiogram (ECG or EKG)
- Heart disease
- Kidney disease
- Lung disease
- Low blood levels of potassium, calcium or magnesium
- Eating disorder (such as bulimia or anorexia)
- Dehydration or persistent vomiting
What types of drugs should Propulsid not be taken with?
Cisapride should not be used by patients taking some of the following types of medications: anti-allergy, anti-angina, anti-arrhythmics (irregular heart rhythm), antibiotics, anti-depressants, anti-fungals, anti-nausea, anti-psychotics and protease inhibitors (anti-HIV infection).
Have children also suffered complications from taking Propulsid?
Although Propulsid was approved for adult use, many children, mostly infants and premature babies, took Propulsid. Some of these infants have died or suffered irregular heartbeats. Of the 70 deaths originally reported by the FDA, 11 were children and 20 children suffered heart rhythm disturbances.
Should patients have any tests done before taking Propulsid?
Yes, a 12-lead ECG should be obtained before Propulsid is administered.
» top
