Common Laxatives Linked to Behavioral Issues and Worse in Children, Experts Warn

Common Laxatives Linked to Behavioral Issues and Worse in Children, Experts Warn
(Illustration by The Epoch Times, Shutterstock, Getty Images)
May 08, 2024
Updated:
May 18, 2024

Bradley Koehler resembled any 4-year-old, always on the move and eager to explore the world around him. Healthy and well-adjusted, he began having episodes of bed-wetting, despite being successfully potty trained.

Alarmed by this regression, his parents sought medical advice. Doctors found that Bradley was suffering from constipation. The retained stool was exerting pressure on his bladder, inadvertently resulting in the nighttime incidents. His medical team prescribed daily doses of MiraLAX to alleviate the condition.

Over the next few years, shifts in Bradley’s behavior alarmed his parents. At soccer practice, he began to lash out, his small legs delivering kicks to his peers in bursts of unprovoked aggression. School assignments, which previously captured his interest, were now met with outright defiance—papers crumpled and thrown on the classroom floor. His parents were concerned but chalked his behavior up to him just “being a boy.”

During this time, his struggles with bowel movements continued. At the age of 8, Bradley began having seizures leading to a diagnosis of temporal lobe epilepsy. Bradley’s distress escalated to saying he “wanted to die,” attempting to leap from the family’s deck and grabbing for kitchen knives. In response, his family turned to UW–Madison Children’s Hospital for psychiatric support.

“In third grade, the wheels really began falling off the bus,” Bradley’s father, Mike Koehler, shared with The Epoch Times. His parents, teachers, administrators, and behavioral interventionists came together to address Bradley’s worsening behavior, which had deteriorated to the point that he required more support than a traditional classroom could offer.
image-5643409
Mike and Bradley Koehler. (Courtesy of Mike Koehler)

The Laxative Connection

image-5643413
It was during a hospital visit in 2015 with Bradley, then aged 9, that a breakthrough came in an unexpected form. A family friend mentioned an article from The New York Times to Mr. Koehler, highlighting concerns over MiraLAX. This prompted Bradley’s parents to consider the possibility that the laxative could be responsible for their son’s significant shifts in behavior and health.

“It was like a lightbulb went off,” Mr. Koehler said.

Their growing suspicions found resonance with numerous other families who reported similar issues following their children’s use of the laxative.

The U.S. Food and Drug Administration (FDA) allocated nearly a million dollars to investigate the potential adverse effects of MiraLAX on children despite the drug not being approved for those under 17. A decade later, this research, assigned to the Children’s Hospital of Philadelphia (CHOP), remains incomplete.

image-5643414
Children’s Hospital of Philadelphia in the King of Prussia, Pa.,  on Nov. 5, 2023. (JHVEPhoto/Shutterstock)

The Epoch Times attempted to contact Dr. Robert Heuckeroth, lead researcher, and Dr. Matthew Hodgson, vice president of research compliance and regulatory affairs, for updates and insights on MiraLAX and childhood constipation. The reply came only from Emily DiTomo, director of public relations, who stated, “Neither Bob nor Matthew is available to speak with you for your article.” When probed further, Ms. DiTomo stated, “Children’s Hospital of Philadelphia does not have any information to share.”

Meanwhile, families like Bradley’s, potentially affected by the adverse effects of a widely used treatment, have been left to resolve the problem themselves.

The Constipation Crisis in Children

Nearly 1 in 10 children worldwide suffer from constipation, contributing to 3 percent of U.S. pediatric clinic visits—a number that escalates to 25 percent in pediatric gastroenterology clinics.
“Functional constipation is common in childhood and is associated with geographical location, lifestyle factors, and stressful life events,” notes research published in The Journal of Pediatrics.

Lisa Santo Domingo, director of the Pediatric Multidisciplinary Chronic Constipation Clinic at Johns Hopkins Children’s Center, suggests the reported figures for constipation in children are too low. “Some parents may underreport or dismiss mild or intermittent symptoms, leading to an underestimation of prevalence rates,” she told The Epoch Times in an email. She added that trends indicate an increasing prevalence of constipation among children in recent years.

image-5645613
Annual health care costs for children with constipation are triple that of children without constipation, $3,430 compared to $1,099. (The Epoch Times)
Treating constipation is not cheap. Children with constipation incur increased annual medical costs of $3.9 billion, according to The Journal of Pediatrics. Health care expenses for children with constipation are three times higher than for those without, and one out of four children carry this issue into adulthood.
Constipation's toll goes beyond physical pain, deeply affecting psychological health.
Practitioners diagnose constipation using the Rome IV criteria, identifying symptoms such as infrequent bowel movements, hard stools, and fecal incontinence. Factors contributing to this condition range from diets rich in processed foods and low in fiber, sedentary habits, toilet training methods, anxiety, medications, and conditions such as obesity and irritable bowel syndrome.
Constipation’s toll goes beyond physical pain, deeply affecting psychological health. Research indicates that children dealing with constipation report a lower quality of life than their peers, encountering greater challenges in relationships and academics and heightened levels of anxiety and depression.
“Children experiencing constipation may feel embarrassed, frustrated, or anxious about their symptoms, especially if they result in accidents or social stigma,” Ms. Santo Domingo said. “Persistent symptoms may lead to absenteeism, decreased academic performance, and social withdrawal.”

MiraLAX: Doctor Preferred

Physicians often treat constipated children with laxatives. Their preferred choice is polyethylene glycol (PEG 3350), or MiraLAX, despite the drug not being approved for those under 17. Praised for its effectiveness, safety, and user-friendly format, MiraLAX powder dissolves in water or other drinks. It pulls water into the intestines to ease bowel movements. PEG 3350 is also present in several other laxatives and bowel preps, including GaviLAX, GlycoLax, ClearLax, and GoLytely, to name a few.
image-5644119
Miralax, is an over-the-counter drug that, along several generic versions, uses PEG 3350 as its active ingredient. (JHVEPhoto/Shutterstock)

According to Ms. Santo Domingo, “MiraLAX is commonly used as a first-line or adjunctive treatment for constipation in children and is generally considered safe and effective when used appropriately.” She highlighted its effectiveness for a spectrum of issues, from mild to moderate constipation to stool leakage, stressing its vital role in treatment and prevention for affected children.

In an email to The Epoch Times, a representative from Bayer, the company behind MiraLAX, shared the laxative’s journey from its initial introduction as a prescription medication in February 1999 to its FDA approval for over-the-counter sales in 2006, specifically for “adults and children 17 years and older for up to 7 days unless otherwise directed by a doctor.”

Despite official recommendations, Bayer references “many independent clinical studies” that affirm PEG 3350’s safety in younger patients, bolstering their support for its pediatric use.

Doctors commonly prescribe MiraLAX off-label for children, supported by organizations such as the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. “In clinical practice ... 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,” they wrote.
image-5645615
The FDA's Adverse Events Reporting System (FAERS) has recorded thousands of potential incidents stemming from PEG3350-based drugs. (The Epoch Times)
According to a search by The Epoch Times of the FDA’s Adverse Events Reporting System, about 39,715 adverse reactions to PEG 3350 have been logged, including 2,607 cases involving children under 18. Experts caution that this may be the tip of the iceberg, suggesting widespread underreporting.

Bayer reassures patients and practitioners, stating, “As part of Bayer’s ongoing commitment to consumer well-being, we regularly track, analyze, and report all adverse event data related to the use of the product.” This vigilance, they argue, reinforces the “continued safe use of MiraLAX.”

“Before recommending MiraLAX or any laxative therapy, we conduct a thorough evaluation,” Ms. Santo Domingo said. “We also provide education and guidance to parents and caregivers on the appropriate use.”

image-5644122
Concerns over the safety of PEG 3350-based laxatives prompted the Empire State Consumer Project to submit a citizen petition in 2012 and demand black box warnings on these products. (Screenshot via The Epoch Times)
In June 2023, Linzess (linaclotide) became the only FDA-approved prescription drug to treat functional constipation in children over 6 years old.

A Decade of Uncertainty

Rising skepticism over PEG 3350’s safety prompted the Empire State Consumer Project to submit a citizen petition in 2012. They urged the FDA to thoroughly examine the safety of PEG 3350 for short and long-term use and demanded a recall to include a black box warning on products.
While not confirming any direct risk to children, the FDA acknowledged the petition’s concerns about insufficient data on PEG 3350’s safety in minors.

“As a result of parental concerns that off-label use of PEG 3350 chronically in children might be causing neurocognitive symptoms, the FDA funded research to develop very sensitive methods to measure the levels of the break-down products of PEG 3350 in blood and urine to be followed by a study evaluating pediatric patients’ potential exposure and extent of absorption of these three break-down products including ethylene glycol (EG), diethylene glycol (DG), and triethylene glycol (TEG),” the FDA told The Epoch Times in an email.

The FDA provided $324,999 to the Children’s Hospital of Philadelphia in 2014 for the research overseen by Dr. Heuckeroth. Targeted for completion in 2015, the study encountered delays, notably in refining techniques to accurately measure PEG 3350 metabolites. Consequently, the initial grant expired on Sept. 30, 2019, leaving the study unfinished.
image-5645617
The FDA has given Children's Hospital of Philadelphia (CHOP) multiple research grants but CHOP says it is challenging to study PEG 3350 effects. (The Epoch Times)

“There have been unanticipated delays due to public health emergencies such as Covid 19 and to technological challenges with method validation,” the FDA stated.

In 2020, the FDA injected fresh funds into CHOP’s ongoing study. The initial award detailed an obligation of nearly $326,000 for the first year, with an option to extend into a second year for an additional $326,000, for a potential award close to $652,799. The study, scheduled to restart in September 2022 with 250 children, is now anticipated to conclude by June, nearly a million dollars and a decade after inception.

“The FDA is committed to ensuring the medicines Americans take are safe and effective,” the agency reported, reiterating that it is “eager to obtain the results.” If the research uncovers new evidence of a safety risk, the agency will take appropriate regulatory action, it told The Epoch Times.

Derek Braslow, a lawyer who previously represented families alleging harm from MiraLAX, expressed his disappointment at the incomplete CHOP study.

“Companies like Bayer have an ongoing responsibility to ensure the safety of their products and the adequacy of the warnings on their label to protect consumers,” he told The Epoch Times in an email. He emphasized that the outcomes, or lack thereof, from the CHOP study do not absolve the manufacturer of its responsibilities.

Discovering potential risks with PEG in children’s laxatives could trigger broader safety concerns, given its extensive use as an additive in various medications, from antibiotics to blood pressure drugs to vaccines.

Parental Outcry on Safety

Amid the widespread use of MiraLAX, a wave of parental concern has surfaced. Many of these parents connect through a Facebook group, Parents Against Miralax Restoralax Movicol (PEG 3350).

“I’m desperate and at a total loss. I just found this group and stopped giving my 16-month-old daughter Miralax immediately, but I’m scared the past 8 months of use (literally half her life) have ruined her,” one mom wrote.

Within the online community of more than 86,500 members, parents exchange advice on managing constipation and share strategies for dealing with the side effects some children experience on MiraLAX. Thousands of testimonials tell similar stories: mood swings, rage, tics, insomnia, seizures, and more.

They also share frustration over doctors dismissing children’s behavioral changes as age-related, overlooking possible connections to PEG 3350. “Trying to help my son with stool withholding and listening to his doctor tell me all bad Miralax claims are ‘debunked’ has been my biggest parenting fail,” a mother shared.

Many parents, such as Mr. Koehler, report drastic improvements after discontinuing PEG 3350. A. 2015 New York Times piece on MiraLAX’s potential side effects shocked Mr. Koehler, prompting him to consult a naturopath and conduct a stool analysis.

The analysis revealed a critical lack of lactobacillus—vital for gut health.

“The discovery was a game-changer,” Mr. Koehler stated. The family began a natural treatment to restore Bradley’s gut bacteria. As his gut started to heal, his seizures stopped, his suicidal ideations vanished, and a more loving and compassionate child began to emerge.

“We saw changes in Bradley that we hadn’t seen in years,” said Mr. Koehler, allowing Bradley to stay in mainstream education. Now a high school senior, Bradley has been seizure-free for six years and medication-free.

“We are convinced MiraLAX eradicated all the bacteria from his gut, allowing candida and yeast to overpopulate,” Mr. Koehler added.

An oddly similar situation unfolded for 4-year-old Conor in 2018 after starting PEG 3350 to treat constipation. Within three weeks, he displayed alarming symptoms: night terrors, teeth grinding, and dark circles under his eyes. Speech regression and angry outbursts were noted at his Montessori school.

“Our happy, intelligent, calm boy was stolen,” Conor’s father, Chris Howie, recalled.

image-5644126
Conor Howie and his father Chris Howie. (Courtesy of Chris Howie)

The discovery of the drug’s potential risks prompted Conor’s parents to seek a naturopathic evaluation, which revealed an overgrowth of harmful bacteria and candida in his gut and a lack of beneficial bacteria. Efforts to improve his gut health led to rapid improvement. “Literally two weeks after healing the gut, the school called to say, ‘Conor’s back,’” Mr. Howie said.

In Edmonds, Washington, a concerned mother who preferred to stay anonymous shared her experience after her son began MiraLAX treatment for constipation in 2021. Just three days into the treatment, her son’s behavior dramatically changed—refusing to get out of the car, shouting in school, and tantrums at home. By the fifth day, her normally talkative boy stopped speaking altogether and engaged in unusual behaviors such as chewing on his shirt, paper, and iPads.

Convinced of the correlation between the medication and these sudden behavioral changes, she immediately halted the MiraLAX, noting: “He was on it for five days. It was the only medication he was taking. It was definitely the MiraLAX.”

Now 7 years old, her son has recovered his speech and is back in school, doing “relatively well.” However, he continues to deal with sensory processing issues, and his speech pace remains slow. His mom suspects the PEG in MiraLAX may have exacerbated an underlying condition. They now vigilantly avoid PEG products, a challenge since “it’s in everything, though: shampoo, cleaning products, even vaccines. We have to be so careful.”

The Prevalence of PEGs

Indeed, these petroleum-based compounds are found in a wide array of products, from cosmetics to baby wipes, where they function as thickeners, softeners, moisture retainers, penetration enhancers, and surfactants. Studies show that up to 72 percent of people have detectable anti-PEG antibodies, pointing to widespread exposure given PEG’s prevalence.
image-5644127
Many products are made using polyethylene glycol (PEG), a petroleum-based compound. It is found in everything from toothpaste and shampoo to cosmetics, soaps, moisturizers, and more. (The Image Party/Shutterstock)

PEG itself isn’t one substance but a category of compounds formed by combining polyethylene with glycol, with each type tailored for specific roles in various products. “Different forms of polyethylene glycol are usually delineated by placing a number after the abbreviation ‘PEG,’ such as PEG-100, PEG-3350, and so on. This number represents the molecular weight of that specific compound,” Dr. Jill Carnahan, a functional medicine doctor, wrote on her website.

According to Dr. Carnahan’s website, PEG derivatives themselves aren’t inherently toxic. However, concerns arise from the production process, which may involve chemicals known for their toxic effects on humans. Additionally, PEG’s role as a “penetration enhancer” can lead to increased exposure to other toxins.

PEGs, commonly used in various products, are associated with allergies, digestive problems, and other health-related side effects. Recently, PEG has drawn particular attention for its potential role in triggering severe allergic reactions to the COVID-19 vaccine, raising concerns about the compound’s contribution to the growing incidence of hypersensitivity reactions.

Exploring the Potential Mechanisms of Harm

Due to a shortage of studies on MiraLAX’s effects on children, the precise ways it may cause harm remain unclear. Some point to the toxic byproducts in pharmaceutical-grade PEG 3350, such as formaldehyde, ethylene glycol, and diethylene glycol—some of which are also in antifreeze.

The Empire State Consumer Project has raised concerns that prolonged laxative use could disrupt the absorption and levels of critical nutrients in children, such as B vitamins and magnesium, which are vital for neuropsychiatric health. They queried the FDA, “If chronic laxative use blocks nutrient absorption or depletes nutrients, what key nutrients can be measured while blood is being drawn for PEG, EG, DEG?”

Stanford University research indicates PEG could decimate gut bacteria within three days.
Another theory posits that PEG exposure may eliminate beneficial gut bacteria, with one study claiming that its use could be considered “bacterial genocide” due to its long-lasting impact on the composition and balance of gut microbiota.
Gut disruption could affect serotonin production, which is crucial for neurological health via the gut-brain connection. Stanford University research indicates PEG could decimate gut bacteria within three days. A 2021 mouse study observed microbiome changes after two weeks of PEG 3350 administration but noted no impact on anxiety-related behavior.
There are also worries PEG 3350 may deplete short-chain fatty acids, such as butyrate, potentially impacting brain health and triggering neuropsychiatric conditions. Research indicates that individuals with ADHD have lower levels of this brain-protective substance.

The Path Forward in Addressing Constipation in Children

Ms. Santo Domingo highlighted the need for a team effort in treating constipation, stating, “Our clinic has published research proving that a multidisciplinary approach, including medical evaluation, dietary modifications, behavioral interventions, and parental support, is necessary to manage constipation comprehensively and optimize children’s health and quality of life.”

Lisa Anderson, known as the “Poop Whisperer,” also champions a multifaceted method. As a clinical holistic nutritionist, she assists many families through her constipation relief program, tackling childhood constipation head-on.

“We have an epidemic of constipation,” Ms. Anderson told The Epoch Times. “Laxatives are a bandaid solution,” she warned, highlighting the risks of their excessive use. Relying too heavily on laxatives can harm intestinal health and lead to psychological reliance, weakening the body’s natural ability to regulate itself.

She noted that while poor diet plays a role, individual health conditions, mental well-being, and genetics also affect constipation.

“Constipation happens to lots of kids, even on a perfect diet. Parents shouldn’t beat themselves up about it,” she said.

“There’s no one-size-fits-all solution.”

She advocates for a regimen that includes magnesium citrate, vitamin C sodium ascorbate, ample fluids, and various healthy fats—strategies she believes can alleviate constipation painlessly.

She stresses addressing the root cause to find a lasting solution, potentially through gut testing.

“There are many reasons for constipation, and to truly heal, we must address the reasons behind why a child becomes constipated in the first place,” she said.

Healing the gut demands a holistic strategy—diet, supplements, mindset, and behavior changes. Progress timelines vary, with notable improvements typically seen within six months, according to Ms. Anderson.

Ms. Anderson encouraged patients and their families: “The body is so resilient. Constipation is not a lifelong sentence.

“There’s hope. With dedication, it’s something that can be resolved.”

AD