Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Polyethylene Glycol (PEG) 3350, the active ingredient in MiraLAX, has increasingly become a serious concern for the parents of children who have been put on this drug.
An earlier post of ours in May 2017, "Growing Concern About Reports Of Children Who Developed Neuro-Psychiatric Problems After Taking MiraLAX" introduced the issues with the PEG 3350 usage:
Despite the fact that MiraLAX is not intended for use by young children, pediatricians and other doctors have been prescribing or recommending MiraLAX use in that patient population for many years, apparently. Generally, this use of MiraLAX by children pursuant to their doctor's guidance is called "off-label" use.
What has reportedly happened to these children (according to their parents) as a result of this long-term usage of PEG 3350, is extreme neuro-psychiatric effects such as: depression, anger, anxiety, paranoia, and mood swings.
In January 2018, our post, "MiraLax Pediatric Study on Psychiatric Side Effects Projected to be Completed in 2018" gives detailed information regarding a citizens' petition to investigate the drug's safety as well as the FDA's response. This includes information about the well-known CHOP study that was supposed to be completed by the end of 2018 and has apparently been suspended indefinitely.
A New Study on PEG 3350 Safety
We now have knowledge of a new study that has taken place in efforts to resolve the continuing concerns of long-term PEG 3350 use in children. On October 4, 2018, Gastroenterology & Endoscopy News published an article, "New Study Tries to Address PEG 3350 Safety Concerns" [registration required - free], which provides a comprehensive summary of the study.
The study included administering a small amount of PEG 3350 (17 g) with tap water to the children and then monitoring their blood samples over a period of 3 hours compared to that of similar children who did not take the drug.
Diethylene glycol, ethylene glycol, and triethylene glycol - compounds which are neurotoxic at high concentrations - were found normally present in all of the participants. From this, they came to the conclusion that using PEG 3350 for long periods of time does not create a hazardous increase in these compounds and therefore, is safe.
Though this new study sought to ease the minds of worrying parents, thousands are displeased with the results and, in fact, are left seeking even more information than before.
First-hand accounts from parents denounce the realities of this study. The article, "New Study Tries to Address PEG 3350 Safety Concerns" [registration required - free], shows that even the authors of the study acknowledge this lack of congruity:
Despite these findings, the researchers acknowledged that "limitations of this study prevent affirming that PEG 3350 does not cause neuropsychiatric events." These limitations included the small sample size, potential variation in susceptibility to PEG 3350–related compounds, and exclusion of children with compromised mucosal barrier function.
We are aware that these inconclusive studies are creating a population of frustrated, information-seeking parents. That being said, our analysis of this possible drug-safety problem is ongoing and we remain open to any new or relevant information parents and medical researchers may have.
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