Few Advancements Have Been Made in Studies Aimed at Linking PEG 3350 and MiraLAX
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
For the past few years, we have reported on the popular over-the-counter constipation drug MiraLAX, and its adverse side effects in children. While the Food and Drug Administration (FDA) continues to fund research for a potential connection between the two, few advancements have been made in the research.
MiraLAX and PEG 3350 Overview
Many pediatricians have recommended parents use MiraLAX to treat chronic childhood constipation in children under the age of 16. However, the drug quickly became a topic of discussion amongst parents, as many parents report behavioral and neurological issues in their children that they claim stem from the child's use of MiraLAX.
Polyethylene glycol (PEG) 3350 is a class of medications, more easily known as "osmotic laxatives". The laxative works by retaining water within the stool to increase the number of bowel movements and softens the stool so it is easier to pass. Typically, PEG 3350 comes in a powder form, and is meant to be mixed with water and taken once a day as needed for up to two weeks, or up to one week for children under the age of 16, as directed by a doctor.
Minimal Progress in PEG 3350 Study
As previously reported in our January 2021 article "Boston Children's Hospital Offers Alternatives to MiraLAX for Constipation Treatment", few advancements have been made in The Children's Hospital of Philadelphia (CHOP)'s FDA-funded PEG 3350 study in relation to MiraLAX and other over-the-counter constipation relief medications.
According to CHOP's Research Institute page on the PEG 3350 Study (Accessed: 7/30/2021), patients have not yet been enrolled for the main clinical absorption study:
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.
According to the website, the FDA has received reports from concerned parents that the component of PEG 3350 in MiraLAX may have caused neurobehavioral symptoms in their children. The CHOP study is aimed at determining is PEG 3350 is absorbed into the blood, but due to the difficulty in measuring the volatile PEG 3350 component, the study is still currently in its first phase.
Additional Information and Sources
While few advancements have been made in terms of PEG 3350 research in relation to MiraLAX use by children, parents and other family members may find comfort in joining the Facebook group "Parents Against MiraLAX". Additionally, you may want to consider referring to our February 2020 article, "MiraLAX: The Quest to Get Answers from the FDA" for more information of past PEG 3350 studies.
As always, we will continue to monitor the issues surrounding MiraLAX and will provide you with any new or relevant information. Please feel free to share any relevant information with us, as well.