PEG 3350 Study

As reported in the media, The Children’s Hospital of Philadelphia’s (CHOP’s) Division of Gastroenterology is conducting an FDA-funded study to determine if components of PEG 3350 are absorbed into children’s blood. PEG 3350 is contained in certain over-the-counter medications commonly prescribed by physicians to treat children with constipation. The FDA has received reports from parents who are concerned that this medicine has caused neurobehavioral symptoms in their children. At this time, however, we are not aware of any scientific study indicating that PEG 3350 is dangerous or causes neurobehavioral symptoms.

Our study seeks to determine if PEG 3350 or its components are absorbed into the blood. As the compounds are volatile and difficult to measure, we are currently in the first phase of the study working with the FDA and researchers at Ohio State University to optimize the laboratory assays. Limited absorption and measurement of the compounds in the blood would suggest that PEG 3350 is not associated with neurobehavioral symptoms; whereas the measurement of significant levels of these compounds would indicate than an association is possible and additional study would be needed to determine whether or not use of PEG 3350 is associated with neurobehavioral symptoms.

We have not begun enrolling children for the main clinical absorption study.  Once enrollment begins, an announcement will be made on the CHOP website. This study is not designed to evaluate children who may have experienced side effects of PEG 3350 in the past and we will not answer questions about use of PEG 3350 containing medicines until our study is complete. Parents should talk to their child’s pediatrician regarding use of products containing PEG 3350 if they have specific questions regarding their child.