Few Advancements Made In PEG 3350 MiraLAX Research
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
For the past few years, we have reported on the adverse reactions of the popular over-the-counter constipation drug MiraLAX. There are many reports of a potential connection between Polyethylene Glycol (PEG 3350), the active ingredient in this constipation medication, and the development of neuropsychiatric problems. The FDA continues researching the potential connection between the two, with few advancements made.
The FDA's Current Position
Currently, there are no products approved by the FDA for the relief of occasional constipation in pediatric patients. However, in 2014 the FDA provided the Children's Hospital of Philadelphia (CHOP) with a grant to study the effects of PEG 3350, the active ingredient in constipation medications like MiraLAX, on pediatric patients. The study was aimed at seeing the extent to which pediatric patients may absorb smaller molecules found in PEG 3350. Unfortunately, the grant period ended on September 20, 2019, before the study was completed.
However, the FDA continues to express interest in completing the study, and is currently looking to secure funding in order to collect additional samples, continue data analysis and draft a manuscript expressing the study's findings. More information on the study can be found in this March 2017 pamphlet released by CHOP. There is no current end date on the study.
Research vs Personal Narratives
While few advancements have been made in terms of PEG 3350 research, many studies continue to support the notion that it is still the best drug on the market for pediatric use of constipation relief. As seen in the March 2017 CHOP informational pamphlet:
PEG 3350 has been studied in children and is often considered the best drug for constipation (see next page). Many children have been treated for months to years.
This idea is further supported in other research articles, such as in a North American Society For Pediatric Gastroenterology, Hepatology & Nutrition January 2015 document "Polyethylene Glycol 3350 (PEG 3350) Frequently Asked Questions":
Is PEG 3350 safe for use in children long-term?
Several research studies have shown PEG 3350 to be safe in children when used for several weeks to several months. Currently there have been no studies specifically on the use and safety of PEG 3350 in children for longer periods of time. In clinical practice, however, it is common for pediatric gastroenterologists to prescribe PEG 3350 for chronic use and there have been no reports of serious, long-term side effects in the medical literature.
Why, then, is PEG 3350 and MiraLAX continued to be reported as "safe" for pediatric patients by these research articles if the concerns of parents and family members about long-term side effects continues to grow?
Additional Information and Sources
While few advancements have been made in terms of PEG 3350 research in relation to MiraLAX, 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.
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