Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Over the past few years we have monitored the issues surrounding the popular over-the-counter drug MiraLAX, whose active ingredient is PEG 3350, that is often used to relieve severe or chronic constipation in children.
We have focused on the adverse reactions that have impacted children as a result of long-term usage of MiraLAX and the lack of action by the FDA to conduct the proper studies, particularly on the possible connection of developing neuropsychiatric problems.
PEG 3350 Study Attempts
We continue today to emphasize how the FDA has failed to provide the public, especially concerned parents, with the scientific data regarding PEG 3350 and the pediatric population. This has been ongoing for more than 20 years, with endless delays.
The Beginning of the Mess
The company who created MiraLAX, Braintree Laboratories, Inc., conducted studies on their powdered laxative product “851" PEG 3350 back in 1996. A Medical Officer Review by Dr. Robert Prizont, MD, at the Division of Gastrointestinal and Coagulation Drug Products gives us information on the studies. Apparently, amidst the study, stool samples were difficult to collect and even lost. Even with the lack of evidence, the company concluded that most of the PEG was non-absorbed in the intestines, stating, “<1 %, is absorbed, and either lingers in the extracellular space for short periods or is rapidly eliminated in the urine.”
Braintree and PREA Waivers
Then in 2010, a Medical Review was published by John E. Hyde, Ph.D., M.D., Clinical Team Leader, DGP at the Center For Drug Evaluation and Research. This time on Braintree Labs product SUPREP Bowel Prep Kit, discussing that a PREA (Pediatric Research Equity Act) waiver could not be applied because it was a completely new drug and there was no prior historical use. The Pediatric Research Committee (PeRC) recommended that studies on the pediatric population should be required. This included comparisons to NuLytely, the only PEG-containing bowel prep product that was approved based on literature review. The lack of information from the SUPREP study resulted in deferral of its Pediatric development plan.
In October 2012, a Memorandum by Erica Radden, M.D., Pediatric and Maternal Health Staff, Office of New Drugs at the Department of Health and Human services, was published. This was in response to Braintree Labs request for a PREA waiver for their product BLI850 (aka "Suclear"), containing sodium sulfate, potassium sulfate, magnesium sulfate, and PEG-3350. Radden supported denial of the waiver, adding, “Furthermore, BLI850, unlike Suprep, contains polyethylene glycol 3350. We are aware of potentially neuro-tox related Aes (e.g., seizures) associated with MiraLax (PEG 3350) in pediatric patients.”
NASPGHAN Q & A on PEG 3350
A January 2015 document titled, “Polyethylene Glycol 3350 (PEG 3350) Frequently Asked Questions” written by the NASPGHAN (North American Society For Pediatric Gastroenterology, Hepatology & Nutrition) Neurogastroenterology and Motility Committee, can be found on the GiKids website. The purpose of this document is to detail what PEG 3350 is, how and why it is used, and its safety. Two of the questions and answers outlined in this document really stood out to me,
6. 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 severalweeks 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.
It leaves us to wonder, if there is so much concern from parents about the long-term side effects, why are there no reports in the medical literature?
8. Why is the FDA sponsoring a new study on the safety of PEG 3350 and what new
information do they hope to find out?
The FDA is interested in investigating the safety of PEG 3350 use in children and for prolonged periods. Although PEG 3350 is a very large molecule which is not absorbed by the gut due to its size, there are concerns that smaller compounds, such as ethylene glycol or diethylene glycol, could be found as impurities in the manufacturing process of PEG 3350 or formed when PEG 3350 is broken down within the body. The FDA is investigating if these smaller compounds are absorbed by the gut and accumulated in the bodies of children taking PEG 3350. Some families have reported concerns to the FDA that some neurologic or behavioral symptoms in children may be related to taking PEG 3350. It is unclear whether these side-effects are due to PEG 3350. This study is the first step towards trying to determine if there is truly a link.
An article of ours from November 2019, "How drugs Like MiraLAX Can Affect The Microbiome," provides some information on how drugs are broken down and can alter our bodies.
You can also refer to our previous articles "Will the FDA Ever Push the MiraLAX Pediatric Study?" or "MiraLAX: Offical Science Effort Regresses while the Public's Investigation Progresses", for more background information on the literature surrounding the issues of PEG 3350 and its studies that have still not yet been completed
We will continue to monitor the issues surrounding MiraLAX and provide you with any new or relevant information. Please feel free to share any information with us as well.
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