The risks and benefits of cisapride in premature neonates, infants, and children
- ANTHONY LANDER, Senior Lecturer
- Paediatric Surgery Institute of Child Health, Birmingham University
- and Birmingham Children’s Hospital, Birmingham, UK
- Birmingham Children’s Hospital
- ASHISH DESAI, Surgical Registrar
- Paediatric Surgery Institute of Child Health, Birmingham University
- and Birmingham Children’s Hospital, Birmingham, UK
- Birmingham Children’s Hospital
The Medicines Control Agency and the Committee on Safety of Medicines (CSM) recently stated that cisapride is contraindicated in infants born before 36 weeks’ gestation for three months after birth, and that there is insufficient data to support the use of cisapride in children up to 12 years of age.1 These statements need qualification. Many believe cisapride to be a safe and useful agent in a variety of intestinal motility disorders especially in premature infants. Furthermore, data seem to support the use of cisapride throughout childhood.
The only support the CSM referenced for their first statement was a study showing clinically asymptomatic electrocardiographic increases in the QTc interval to > 450 in seven of 49 neonates, six of whom were born ≤ 33 weeks’ gestation.2 This gives reason for caution but not contraindication.
Concern relates to QTc > 450, which may predispose to arrhythmias and are a risk factor for sudden infant death (SID).3Increases in QTc and arrhythmias …
