In 2014, the U.S. Food and Drug Administration (FDA) awarded a grant of nearly $325,000 to the Children’s Hospital of Philadelphia (CHOP) to study the side effects of the osmotive laxative MiraLAX in children. The call for this investigation came after thousands of parents filed MiraLAX related adverse reaction reports and the advocacy group the Empire State Consumer Project expressed concern. MiraLAX adverse reactions in children reported by parents included tremors, tics, anger and obsessive compulsive behaviors.1
Unfortunately for many parents with questions, the grant period ended five years later and before the study was completed.2
MiraLAX Not Approved for Those Under Age 17
Licensed by the FDA in 1999, the active ingredient in MiraLAX is known as PEG 3350 or polyethylene glycol. Despite being the number one prescribed laxative for children, MiraLAX is not recommended for anyone under 17 years of age, However, doctors are prescribing it off-label for children. The FDA has stated there is little data on the absorption of MiraLAX in children and the regulatory agency has never licensed MiraLAX for long-term daily laxative use, even in adults.3
According to Children’s Mercy Pediatric Partners, “most kids need 6-12 months of regular MiraLAX use”4 despite the drug insert stating the product should be used for two weeks or less and that “safety and effectiveness in pediatric patients has not been established.”5
A private Facebook page called Parents Against MiraLAX has almost 85,000 members and is described as…
… a group of parents and family members who are very suspicious of PEG 3350 and are here to discuss its effects on our children. We discuss alternative options, focusing on healing the gut naturally, and ways to talk to doctors about our opposition to this very dangerous drug.6
Paranoia, Mood Swings, Aggression Among Behaviors Noted With MiraLAX Use in Children
One mother described her daughter’s dramatic change in behavior to ABC Action News as “Near psychiatric events with paranoia, mood swings, aggression, rage, the OCD repetitive chewing,” and stated that she saw her daughter change drastically after taking her off MiraLAX for just 10 days.3 Many parent’s stories within the Facebook group echo similar experiences.
Ritu Verma, MD, a gastroenterologist at CHOP where the MiraLAX study in children was conducted and halted before it was completed, defended the laxative drug. She stated that MiraLAX was effective and their go-to treatment for children. “We do not at this time have any information at all to say that this is an unsafe medication,” Dr. Verma stated.3
FDA Says Insufficient Data to Demonstrate Link
The FDA told ABC Action News that there was “insufficient data to demonstrate a link between PEG 3350 and serious neuropsychiatric issues in children”, citing only 167 adverse events reported to the FDA. However, upon further investigation, ABC journalists dug through a 3,900-page document of over 14,000 adverse reports related to MiraLAX through 2016. The FDA responded and confirmed the numbers, but said there were several limitations and that the adverse reaction reports do not necessarily prove a relationship between the drug and the adverse reaction.3
Data as of Dec. 31, 2023 showed there had been 34,453 adverse reactions following use of MiraLAX filed with the FDA adverse Events Reporting System (FAERS) available on the public dashboard. Of those MiraLAX reactions, 2,550 were serious cases, including death.
A statement from the FDA reads:
The FDA has considered these reports… and at this time does not believe additional warnings or other changes are warranted.7
FDA Did Not Disclose Trace Amounts of Ethylene Glycol Found in Drug Samples
Tests conducted by the FDA in 2008 found small amounts of ethylene glycol (EG) and diethylene glycol (DEG), also ingredients in antifreeze, in all batches of MiraLAX that were tested. The testing was performed because adverse events reported after use of MiraLAX resembled classic symptoms of central nervous system (CNS) dysfunction after toxic ethylene glycol poisoning, which include irritation, restlessness, disorientation, visual and hearing disturbances, convulsions.8 However, the results were never disclosed.
Manufacturers refused to comment on the impurities. It is still unknown if small amounts of EG or DEG are present once metabolized and if they can harm children, especially those given MiraLAX on a long-term basis.1
Source: Laxative Drug MiraLAX Side Effect Reports Include Brain…