Cisapride Is Not Safe for GERD Management Due to Serious Cardiac Risks
Cisapride should not be used for the management of gastroesophageal reflux disease (GERD) due to its association with serious cardiac adverse events including fatal arrhythmias and sudden death. 1, 2
Safety Concerns and Regulatory Status
- Cisapride was removed from the US market because of reports of serious cardiac adverse effects:
- 341 cases of ventricular arrhythmias including 80 deaths were reported to the FDA 2
- The drug can cause QT interval prolongation, predisposing patients to potentially fatal cardiac arrhythmias 2
- Since July 2000, cisapride has been restricted in the USA and Europe to limited access programs supervised by pediatric gastroenterologists 3
Efficacy Evidence
Despite the safety concerns, the evidence for cisapride's efficacy in GERD is mixed:
- A Cochrane systematic review found no clear evidence that cisapride reduces symptoms of GOR in children 3
- While cisapride did reduce the reflux index in some studies (weighted mean difference -6.49; 95% CI -10.13 to -2.85), this physiological improvement did not consistently translate to clinical symptom improvement 3
- An earlier review noted that cisapride was "of limited value in maintenance therapy of GORD in patients in whom symptom relief has been accomplished with potent antisecretory medication" 4
Current Recommended Alternatives for GERD Management
Proton Pump Inhibitors (PPIs):
H2-Receptor Antagonists:
- Effective alternatives for milder cases 5
- Examples: ranitidine, famotidine
Lifestyle Modifications:
- Weight loss if overweight/obese
- Avoiding meals 2-3 hours before lying down
- Elevating the head of bed 6-8 inches
- Avoiding trigger foods
- Smoking cessation 5
Important Considerations for Special Populations
Pediatric patients: The American Academy of Pediatrics specifically notes that there is insufficient evidence to support the routine use of any prokinetic agent for the treatment of GERD in infants or older children 1
Pregnant patients: A step-up approach is recommended, starting with lifestyle modifications, then antacids, sucralfate, H2-receptor antagonists, and finally PPIs for refractory cases 5
Conclusion
The risk-benefit profile of cisapride for GERD management is clearly unfavorable. The potential for serious cardiac adverse events, including fatal arrhythmias, far outweighs any potential benefits, especially when safer and more effective alternatives like PPIs are available. Current guidelines do not support the use of cisapride for GERD management, and the drug remains available only through restricted access programs in most countries.