The Children’s Hospital of Philadelphia is investigating the safety of polyethylene glycol 3550 for treatment of constipation in the pediatric population, according to a press release.
The FDA-funded study aims to determine if certain components of PEG 3350 that are present in over-the-counter medications commonly prescribed for constipation in children are absorbed into the bloodstream, and if so, whether it causes adverse effects, the release explained. According to the NIH website, these components include “low molecular weight (LMW) species that may be found in PEG 3350 products (e.g., ethylene and diethylene glycol) and … PEG 3350 metabolites.” Although chronic use of PEG 3350 and use in children younger than 17 years is not approved by the FDA, it is used as such in clinical practice, according to the website.
It is currently believed that PEG 3350 is poorly absorbed into the blood, but reports from parents to the FDA of neurobehavioral symptoms in their children have prompted further investigation, the release stated. “A number of these pediatric patients received an adult dose of PEG (17 grams) for a duration ranging from a few days to a couple of years,” according to the NIH website.
“At this time, we are not aware of any scientific study indicating that PEG 3350 is dangerous or causes neurobehavioral symptoms,” the release said.
The study will evaluate three groups of children who have been receiving a PEG 3350-containing laxative for 1 month or more:
- Children who are healthy aside from constipation
- Children with bowel disorders (ie. IBD)
- Children with underlying neurological or neurobehavioral conditions
Controls not taking laxatives will also be included to determine the presence of PEG 3350 components in their blood.
Investigators in the division of gastroenterology at CHOP will be conducting the study but have not yet begun enrolling participants, according to the release. An announcement will be made when enrollment begins.
“Our researchers are very interested in working with the FDA to assess the safety of this medicine in children,” the release said.