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Is MiraLAX safe for children?

Ingredient in popular over-the-counter drug raises questions

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DETROIT – For many parents with constipated children, the over-the-counter drug MiraLAX has provided some much-needed relief.

Parents are able to mix the powdery, tasteless substance into a beverage, hand it over to their child, and the medication is very effective at getting the system moving. MiraLAX is affordable, it doesn’t require a prescription and it’s sold at most major grocery stores and drug stores.

However, a group of parents on Facebook alleges that the active ingredient found in MiraLAX is not as harmless as it may seem. They’re voicing their concerns on the private page, "Parents Against MiraLAX (PEG 3350)" -- which had more than 17,000 members as of Wednesday -- to discuss the ingredient, called polyethylene glycol 3350, or PEG 3350.

Many moms and dads have posted that pediatricians advised that their kids -- even their constipated babies as young as 9 months old -- take MiraLAX, in some cases, like it’s water: adult-sized doses, for extended periods of time.

And parents are reporting scary side effects in their children, including anxiety, behavioral issues, speech problems and depression.

It’s tricky to figure out what’s true, because not a lot of research has been done.

What we know

In 2014, the Children’s Hospital of Philadelphia was given a $325,000 grant from the Food and Drug Administration to study PEG 3350, which is the ingredient in MiraLAX that increases the frequency of bowel movements and softens the stool.

But until the study is complete, the hospital won’t comment on specific cases, or any of the findings.

View original grant notice

A grant notice is an official document that lets whomever requested the grant know that the project was approved and the funding will be made available.

"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 said. "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."

Questions arise

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 isn’t much data on how exactly PEG 3350 is absorbed in children, the FDA said, especially those who are very young and chronically constipated. In fact, the agency never approved long-term daily use of the laxatives, even in adults.

In a phone call, Tiffany Smith, a spokeswoman for Bayer, confirmed that MiraLAX is not "labeled for use" for children.

Smith provided a statement from Bayer, saying, in part, "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 complete statement can be found at the bottom of this story.

But still, it seems as though 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 of the parents in the private Facebook group have been posting online that they too believe their kids display neurological or psychiatric symptoms due to PEG 3350.

Recent reports

A local news station in Philadelphia, Action News ABC 6, posted a story online last month, citing several worried and upset parents. Last week, the station published a follow-up report after talking to even more concerned moms and dads.

"I feel like my son was absolutely robbed of most of his childhood," parent Jessica Aman said in one report.

Said another mom of her son, "He had the rage, fears, phobias (and) anxieties."

A group of families approached Action News with the disturbing claims. And in the latest report, Action News said the study at the Children’s Hospital might not have even started yet.

“Researchers in (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,” reads a statement from the Children’s Hospital of Philadelphia.

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.

Antifreeze? That sounds alarming.

So we asked a medical expert.

"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."

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 continued, saying 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 a fan 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.

Another perspective

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.

So what's next?

Perhaps the next question for concerned parents should be, why is constipation such a problem -- especially childhood constipation in the United States?

The Facebook group making headlines has hundreds, if not thousands, of posts on its wall from different parents telling their own stories with kids who struggle to “go.”

Many of the parents write about switching their children off MiraLAX and going a more natural route: adding more fiber to the kids’ diets, as McGeorge recommended, or, giving the children more water and some good old prune juice, which has been a tried-and-true method seemingly since the dawn of time.

 

 

It might feel like a confusing time right now for parents of constipated babies or children, especially considering all the attention MiraLAX has received from a variety of outlets over the past month or so.

Even the Facebook group doesn’t claim to have all the answers, describing itself like this: "We are a group of parents and family members who are against PEG 3350 and are here to discuss its cons. We discuss alternative options and ways to talk to doctors about our opposition to this very dangerous drug. We are not a replacement for the type of health care you choose; we only speak from experience. You have to make your own choices and decisions based on your child and research."

You have to make your own choices. For now, the study is just a study: something to be aware of, especially if you have a son or daughter regularly taking laxatives regularly, but again, nothing is known just yet.

The issue revolves around how PEG 3350 is absorbed in the body, with the idea that absorption of PEG in kids might be greater than in adults. So if you're concerned, consult with your doctor, do your research and hopefully, we’ll all learn more soon.

Perhaps all the chatter is just something to consider and keep in mind, if you have, or know, a constipated child.

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Bayer's full statement:

The MiraLAX® brand became part of Bayer’s OTC portfolio in the United States in October 2014 with the acquisition of Merck Consumer Care. MiraLAX is an osmotic laxative that relieves occasional constipation. MiraLAX was introduced as a prescription laxative in February 1999 and was approved by the FDA as an OTC medication in 2006. OTC labeled dosing applies to adults and children 17 years and older for up to seven days, unless otherwise directed by a doctor.

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.

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. Results of this ongoing monitoring support the continued safe use of MiraLAX.

With regard to the clinical study in question, it is a government-funded study by the National Institute of Health being conducted by the Children’s Hospital of Philadelphia. As Bayer is not involved in the study, any inquiries should be directed to them.


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