A recent retrospective study (D Roy et al. JPGN 2021; 72: 683-689. Full text: Utilisation and Safety of Polyethylene Glycol 3350 With Electrolytes in Children Under 2 Years) provides some reassurance that use of polyethylene glycol 3350 (PEG) (aka Miralax) was well-tolerated in children <2 years of age.
From an initial cohort of 20,861 from the Clinical Practice Research Datalink (CPRD) GOLD, the authors identified 13,235 patients with a constipation indication and 40 patients with fecal impaction indication for PEG.
- The safety aspect of this study did not identify any signals of concern in the constipation cohort.
- The mean duration of exposure, in the first treatment episode, was 88.9 days.
- 9380 patients (70.9%) were aged between 12 and <24 months, with a further 3855 patients (29.1%) aged <12months. Also, PEG 3350+E was used in 477 patients (3.6%) who were <6 months of age
This type of retrospective study is less capable of detecting adverse events than a prospective study and is limited by how carefully the primary care provider elicits and documents them.
My take: This large study confirms the widespread usage of PEG in young children without apparent adverse reactions.
Related blog posts:
- Which is Safer and More Effective: PEG 3350 (Miralax) or Lactulose?
- Expert 2017 Opinion: Miralax is (Still) First Choice Laxative in Children
- PEG 3350 is Not Associated with Elevated Glycol Levels
- Low Adherence Rate with Polyethylene Glycol
- Here we go again…Mirialax Safety
- Miralax -More Scrutiny, Research Study
- Updated Pediatric Expert Constipation Guidelines
- Miralax Safety | gutsandgrowth
- Data Supporting Miralax | gutsandgrowth