When Mike Koehler’s son was 4 years old, a urologist diagnosed the child with chronic constipation and recommended daily doses of the over-the-counter laxative MiraLAX, according to the family.
“He was on it for almost five years,” Koehler told Channel 4 sister station News 6 in Orlando.
As his son entered third grade, the father said he noticed a troubling change in the boy’s behavior.
“He was pushing kids out of line. He was punching kids for no apparent reason,” Koehler said. “He would stomp on his (soccer) teammates’ feet to the extent he’s making them cry.”
The child, who Koehler requested that News 6 not identify by name, became angry and dark.
“There were times where he actually tried to jump off the second-story deck (of the house),” Koehler said.
“He just wanted to be dead, and that was frightening.”
Around the same time, the father said his son was diagnosed with epilepsy and began suffering mild, non-convulsive seizures.
Despite help from a psychiatrist and neurologist, Koehler said his son’s behavior and medical issues improved very little until the family began experimenting with his laxative doses.
“We finally realized once we would give him the MiraLAX, he would have seizures,” Koehler said. “It took us a little bit to connect these dots.”
Koehler claimed the then 9-year-old’s problems vanished almost immediately after he stopped taking MiraLAX.
“The transformation we saw was amazing. It’s like our son came back to us,” Koehler said. “We no longer have the aggression. We no longer have the rage, the defiance, the impulsiveness.”
Koehler is among a growing number of parents who believe MiraLAX may be causing neurological and psychiatric health issues in children.
The online group had more than 18,000 members as of Wednesday.
Numerous parents reported that pediatricians are recommending adult-sized doses of the laxative for children as young as 9 months old, and in some cases, for extended periods of time.
Parents also describe troubling side effects in their children, including anxiety, behavioral issues, speech problems and depression.
What we know
In 2014, the U.S. Food and Drug Administration awarded a $325,000 grant to Children’s Hospital of Philadelphia to study polyethylene glycol 3350 (PEG 3350), the active ingredient in MiraLAX that increases the frequency of bowel movements and softens the stool.
“Researchers in (the hospital’s) Division of Gastroenterology who will be conducting the study have not begun enrolling children, but once enrollment begins, an announcement will be made,” read a statement from the pediatric hospital.
Until the study is complete, the hospital won’t comment on specific cases or any findings.
A grant notice is an official document that lets whoever requested the grant know that the project was approved and the funding will be made available. You can read background information and details about what the study hopes to find in the link above.
"Polyethylene glycol laxative is approved for over-the-counter use for occasional constipation in adults and children 17 years of age and is recommended for short-term use up to seven days," the notice says. "Use in children less than 17 and chronic use is not approved by the FDA, but nevertheless, the laxative is used as such in clinical practice."
So, without FDA approval, why is MiraLAX being recommended for people younger than 17?
The New York Times reported on PEG 3350 in January 2015, saying MiraLAX and similar laxatives have been recommended by doctors for their convenience and on the grounds that very little PEG 3350 is absorbed in the intestines.
But there is not much data detailing how PEG 3350 is absorbed in children, the FDA said, especially those who are very young and chronically constipated.
The agency never approved long-term daily use of the laxatives, even in adults.
The manufacturer of MiraLAX, Bayer, acknowledges that the laxative is not recommended for children but believes it is safe.
"While MiraLAX is not labeled for use in the pediatric population, there have been many clinical studies conducted with PEG 3350 in pediatric populations, which have demonstrated safety for short- and long-term use in children with a history of chronic constipation," the company wrote in a statement to News 6.
However, the federal government suggested not enough is known about the effects of PEG 3350 in children.
"The Food and Drug Administration has received a number of reports of adverse events in children taking PEG products," the grant notice states. "The (FDA) has conducted a review that documented a number of reports of neurological and psychiatric events associated with chronic PEG use in children. A number of these pediatric patients received an adult dose of PEG (17 grams) for a duration ranging from a few days to a couple of years. Whether the PEG contributes in some way to these adverse events is not clear at this time. Some children may be more susceptible to the adverse effects of PEG, especially when high doses are given or after prolonged use.”
Many members of the Parents Against MiraLAX Facebook group reported that their children have also displayed neurological or psychiatric symptoms, which they attribute to PEG 3350.
Did MiraLAX lead to murder?
When Warren Williams was 12 years old, the once outgoing and well-behaved boy abruptly became withdrawn, according to his mother.
“We thought maybe he was being bullied at school,” Anne Williams told News 6. “He started whimpering a lot at night. He couldn’t sleep. He was having night terrors (and) night dreams that would wake him up.”
When Williams and her husband took their son for a mental health evaluation, she said the child was involuntarily institutionalized for three days under Florida’s Baker Act.
“They said we have to admit him because he will not talk, and he might possibly be suicidal,” said Williams.
When Warren returned home, the family noticed his behavior had returned to normal.
At the time, they did not connect his problems to MiraLAX, which a pediatrician had recommended about three weeks earlier for constipation, according to Williams.
“No one in their right mind thinks an over-the-counter laxative is going to do this to anyone,” Williams told News 6.
So two years later, when a doctor recommended Warren resume taking MiraLAX, the family did not question the medical advice.
“I've been a nurse for over 38 years, and my thoughts were (the doctor) knows what she's doing, so I'm going to do what she says,” Williams said.
Six days later, Williams left her son and husband, Bill, at home while she attended a school function.
“When I left to go to the PTA meeting, they were outside walking around the house with our dogs,” Williams said. “When I came home, there were police cars and crime scene tape. (Warren) had shot and killed my husband in the span of an hour.”
In a 911 call Warren placed immediately after the shooting, the 14-year-old told a dispatcher it was no accident.
“I’m sick of my life, and I wanted to shoot him,” the teen said. “I wanted to leave and do something.”
Warren Williams later pleaded guilty to second-degree murder.
A judge sentenced him to 20 years in state prison.
The teen’s lawyers explored the possibility that Warren suffered from depression as a result of his older brother’s suicide in 2003, according to published reports.
Anne Williams said her son’s attorneys were also looking into the possibility he suffered from a pre-existing mental illness.
“My son is not bipolar,” Williams insisted. “He was affected by a drug. That drug was polyethylene glycol.”
Williams is not trying to get her son’s prison sentence reduced or altered by claiming the laxative played a role in her husband’s murder.
“He says, ‘Mom, what's done is done. We cannot change it,'” Williams told News 6.
Instead, Williams is hoping her family’s tragedy will give other parents pause before administering MiraLAX to their children.
“Doctors can choose to be willfully blind and put their head in the sand and not listen to parent after parent after parent,” Williams said. “Or they can start paying attention and start realizing perhaps there's something to this.”
Philadelphia television station WPVI has published reports about MiraLAX concerns, citing several worried and upset parents.
In a follow-up report, the news organization discovered that 950 children have reported adverse events to the FDA after taking the laxative.
What is PEG 3350?
When the FDA grant was given to the Children’s Hospital, the federal agency disclosed that MiraLAX powder contains small amounts of PEG 3350, which may, under certain conditions, degrade into ethylene glycol, or diethylene glycol — the ingredients found in antifreeze.
"The concern about it containing ethylene glycol is not completely insane, but the quantities would have to be incredibly small for the FDA to consider it safe for human consumption," said Dr. Frank McGeorge, a health reporter who works for WDIV-TV in Detroit, and also as an emergency room doctor.
"While it is always hard to completely dismiss a group of parents who have serious concerns, the link between a behavior change and the use of MiraLAX would be difficult to prove without many more controlled studies,” McGeorge said.
When asked if he thought it seemed normal for children to take MiraLAX on a regular basis, McGeorge said that was an interesting question.
"Generally speaking, I don't think anybody should be taking MiraLAX on a daily basis," he said. "If you require MiraLAX on a daily basis, you either have something wrong with your intestinal motility, or you should change your diet -- (add) more fiber, for example."
McGeorge said that in children, in particular, it doesn’t seem like an especially good idea to take any kind of laxatives daily.
"Occasional use (even for two days in a row) for some expected constipation related to travel or a period of inactivity, or some dietary indiscretion, for example, is not unreasonable," he said.
But McGeorge said he’s not in favor of using bowel motility agents regularly.
"It is just not the way our intestines were intended to function," he said. "In certain cases, if someone has a known diagnosis involving a motility disorder, then it is reasonable. But that is with a known diagnosis requiring a daily dose of a laxative, or motility agent."
Different laxatives can work in different ways, McGeorge said.
Some are bulking agents, some are motility stimulants, and some hold water in the intestinal lumen. That’s another important consideration in the agent chosen -- especially if it is being used long-term, McGeorge said.
Pediatric neurologist Dr. Jonathan Mink said there are other scenarios that might that might explain the issues some parents report.
“I see an awful lot of children who have neurobehavioral syndromes, like Tourette syndrome, attention deficit hyperactivity disorder, autism and anxiety, and constipation is a common problem in those children,” he told CBS News.
A recent report from the Washington Post addressed gut health and constipation, and mentioned medications such as MiraLAX, posing the question, “Why not give children a commercial laxative?”
“The active ingredient in these medicines is polyethylene glycol 3350 (PEG 3350), which is a derivative of petroleum and is therefore essentially a plastic. Many children take them, and more often than is healthy or necessary,” the author said. “In 2014, the FDA awarded a grant to the Children’s Hospital of Philadelphia to study whether PEG 3350 is absorbed into the blood by children and whether it contributes to neurological or behavioral problems such as seizures, tics, headaches, aggression, rages, obsessive compulsiveness, anxiety and kidney problems. The natural remedies for constipation ... might be preferable until more is ascertained from this study.”
However, in a Letter to the Editor published March 3 by the Washington Post, a pediatric gastroenterology nurse practitioner said she was upset by the February report.
“Reporting that polyethylene glycol (MiraLAX) is being studied to see whether “it contributes to seizures, tics, headaches, aggression, rages, obsessive compulsiveness, anxiety and kidney problems” will likely instigate undue fear in parents with children who are being successfully treated with MiraLAX for their chronic constipation.
“Although the (study) may not yet be complete, the known safety profile of MiraLAX is very good and its use has been recommended by the American Gastroenterological Association and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition in position statements on the treatment of constipation.”
Read more of Lori Stern Olney’s letter.
“MiraLAX is causing neuro-psychiatric health issues,” said Koehler, who is convinced the laxative should not be given to children. “MiraLAX almost destroyed our family, and it almost destroyed a young man."
“This topic is just beginning to be uncovered,” said Anne Williams, who is equally certain MiraLAX harmed her son. “I truly believe it is the story of the century.”