Is MiraLAX Safe for Children?

An adult size toilet next to a child size toilet. Photo by Leonora Enking.

In the small print on the side of a bottle of MiraLAX, you’ll learn that it’s recommended by the manufacturer only for people 17 years of age and older and that it should be used for no more than 7 days at a time.

But MiraLAX is given to many young children daily for months at a time – sometimes even for years.

MiraLAX and similar medications are laxatives and stool softeners using polyethylene glycol (PEG) 3350 as the active ingredient. These medicines are very widely used, work well, and are well tolerated by most children – so much so that the North American Society for Pediatric Gastroenterology, Hepatitis, and Nutrition (NASPGHAN) includes the long-term use of PEG-3350 products in its guidelines for managing pediatric constipation.

A recent pooled analysis of 18 randomized controlled studies suggests that PEG-3350 works better for childhood constipation than some other common medications and based on available evidence appears as safe as other medications.

But PEG-3350 has not been approved by the FDA for use in young children or for use by anyone for more than 7 days. The New York Times reported in early 2015 that the Food and Drug Administration has raised concerns about the use of PEG-3350 in kids, especially over the long-term:

  • We know that only minimal PEG-3350 is absorbed into the body of adults taking the medicine, but very little is known about absorption in young kids – especially those with chronic constipation or intestinal diseases.
  • PEG-3350 is available over-the-counter, so there may be little in the way of medical monitoring or oversight.
  • PEG-3350 powder is stable, but we don’t know what happens to the chemical compounds if there is a delay between mixing with water and giving a dose to a child.
  • Kids are sometimes given adult doses.
  • We don’t know enough about the safety of giving PEG-3350 for weeks or longer.
  • There have been some neuropsychiatric adverse events reported to the FDA in kids taking PEG-3350, which include “seizures, tremors, tics, headache, anxiety, lethargy, sedation, aggression, rages, obsessive-compulsive behaviors including repetitive chewing and sucking, paranoia and mood swings.” We do not know that any of these were caused by the medicine – but we’re not sure that they are not. Many kids who are referred to a pediatric gastroenterologist already have a neuropsychiatric issue before any treatment. The gut and the brain are closely connected.

The good news is that FDA has now awarded a grant to study PEG-3350 in kids to get the information we need. I’m excited about this.

In the meantime, our understanding of MiraLAX is already better than of many medicines used in kids. There is a potential for adverse effects with any medicine. With any medicine we should weigh the benefits of using it against these potential adverse effects.

Talk with your doctor about constipation – especially if it lasts longer than a week.

When practical, I’m a fan of using flaxseed as a gentle food solution for constipation. You can get Bob’s Red Mill Organic Golden Flaxseed Meal at the grocery store. I’ve seen good results with a tablespoon daily, taken with food or fluids. Or flaxseed oil for more stubborn constipation.

I also like weakly brewed Smooth Move Peppermint tea – with senna, a time-honored way to get things moving in the short run. The peppermint and fennel are added to be gentler on the tummy.

Beneficial bacteria are an important part of healthy poop. Nurture these bacteria with good food, avoid killing them from unnecessary antibiotics, and replenish them with probiotics as needed.

Often, the combination of real food, plenty to drink, and going at the first signal can help keep things on track.

References:

  1. Cochrane Review: Osmotic and stimulant laxatives for the management of childhood constipation (Review). Evid Based Child Health. Jan 2013; 8(1):57-59.
  2. Scrutiny for Laxatives as a Childhood Remedy. The New York Times. Jan 5, 2015.
  3. FDA Drug Safety Oversight Board Meeting, June 18, 2009.

Dr. Alan Greene

Dr. Greene is the founder of DrGreene.com (cited by the AMA as “the pioneer physician Web site”), a practicing pediatrician, father of four, & author of Raising Baby Green & Feeding Baby Green. He appears frequently in the media including such venues as the The New York Times, the TODAY Show, Good Morning America, & the Dr. Oz Show.

  1. Pseudo Nym

    Interesting article. I would add the following: although I am 72, this may still have meaning in the context.

    My brother, a colon specialist, recommended I take PEG 3350 daily for a very problematic colon motility disorder (apparently a part of Parkinson’s). I began to do so several years ago.

    A while after that (I now realize) I began to develop (first) episodes of much worsened balance problems and (new) periods of moderate to severe disorientation … and the feeling that my brain was floating around in, or banging around in, my skull.

    Some time still later these conditions became constant, and I was almost completely disabled by them for 2.5 years. I spent that time trying to determine what if anything I could change (I only took one other medication, levothyroxine, and knew it wasn’t the problem) in diet and so on to help. NOTHING did. I could just barely make it back and forth to the store and nothing else.

    The last thing I tried eliminating, because I was told it never even entered my system, was eliminating the PEG 3350 (“Miralax”).

    Over a period of days and weeks my symptoms got VERY much better. Now after 5 months I would say they are about 70% better … but still bothersome. I have to wonder whether, if I had never taken the PEG for long term, I would have developed these symptoms at all (at this time). While these symptoms were at their worst, I was constantly nauseated by them and in great distress, and could not relax or enjoy even a moment. Driving the short distance to the store was a nightmare because I actually lost the “stream of consciousness” that keeps our minds updated as to our visual perceptions (such as “Is the stoplight still green?”).

    My theory is that the “not absorbed” tale of the action of PEG is, if at all true, true for those who have normal colon mucosa (mucus producing layer) that forms the barrier that PEG and many other medications (and other non-food substances) have a struggle to get through. I observed long ago that my dysmotility problem seems in part to be a deficiency in colon mucus.

    I believe that this is one mechanism whereby there is at best an unknown chance that significant amounts of this chemical are indeed absorbed (plus any contaminants). I am here to testify that in case it (any of it) is indeed absorbed, it may wreak havoc in the brain. The only other possibility that occurs to me is that it prevented formation or absorption of some nutrient, but no such problem (lack) showed up in blood tests.

    When I began to read that many doctors are prescribing PEG’s for long term use in children I became very concerned. I would say that certainly one should exercise extreme caution in this matter. “Miralax” truly is a miracle in terms of managing an intractable problem with colon dysmotility, taken long term. However, for some it may be best to stick with “less perfect” solutions. I cannot stress too much the need for caution, here. When I get a chance (and a bit more information) I will make an adverse event report to FDA in case it helps.

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    • Pseudo Nym

      I forgot to add the possibility that (MOA with regard to the problems with ‘Miralax”) in some, if not in many or all, PEG 3350 may actually impair the action of the colon mucosa (as well as the small intestine too?) and be a hazard of even greater magnitude, in addition to self-promoting its absorption, in light of the protective function of this vital part of the operation of the gut. These things need to be investigated prior to any long term use of this product, in my admittedly “lay” opinion (yet one born of possible and perhaps likely experience)..

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      • This is extremely interesting and an important story. Please do report your adverse event.

        Thank you so much for sharing your experience.

        @MsGreene

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        • Pseudo Nym

          Thank you. I will do so soon. Thank you all for this site and the opportunity to relate information.

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  2. Mike Koehler

    I appreciate your review of Miralax however, I wanted to point out a few things the article fails to mention;
    In 2008 the FDA found diethylene and elthylene glycol in all 8 lots they tested. Sure, it’s a small amount and sure it’s “approved” under the guidelines for the manufacturing of the product. We are not using this product for what it’s “approved” for. It’s not approved for anyone under the age of 17 and it’s not approved for use longer then 7 days; what affect do these toxins have on the pediatric patient(s) when using it for months or years? Many of the symptoms brought to the FDA’s attention are similar to ethylene glycol toxicity. With that said, there’s not one study that discusses the amount of PEG 3350 absorbed in the gut; is that number going to vary if the patient is impacted? How about obstructed? Not to mention, this product is contraindicated in patients that are obstructed!! Mayo Clinic mentions that impaction can lead to obstruction;
    The number of adverse events being reported to the FDA is skyrocketing; I saw a report from the FOIA dated 2/2015 and the number of cases was 9,073. I just saw another report from 9/2015 and the cases skyrocketed to 10,909 for an increase of 1,836 new cases in 7 months.

    I’m glad you mention alternatives to miralax, miralax is just a band aid and really shouldn’t be considered when treating people that are dealing with constipation!!

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