Movicol (polyethylène glycol 3350 with electrolytes [PEG 3350+E], Norgine, UK) is authorised in the United Kingdom for chronic constipation in children aged 2-11 and 5 years of age for faecal impaction (FI). The purpose of this study is to explore the use and risk profile of PEG 3350+E in children under the age of 2 in the UK. The participants identified through the GOLD Clinical Practice Research Datalink (CCPRD) retrospective single exposure cohort study. Patients were first prescribed PEG 3350+E for constipation or FI therapy under 2 years. The constipation indicator included 13.235 participants and 40 FI patients. For the group of constipation: median age of PEG 3350+E was 1.2 years and 68.4% had one therapeutic episode (TE). 0.5% of patients suffered abdominal pain, 3.0% suffered diarrhoea and 4.1% vomiting incidents with treatment. 2.0% showed signs/symptoms, but none showed abnormal electrolyte readings, which may be linked with electrolyte disorders.
There were no signs of concern in the constipation cohort in the safety part of this trial. If information was available, a safety researcher would preferably evaluate treatment consumption per kilogramme, including the intake of electrolytes, prior to arriving at safety findings. However these statistics contribute to the fact that PEG 3350+E is used by this group in real-world evidence.
