By Steve Hodges, M.D.
My phone buzzes after every media report suggesting Miralax triggers psychiatric problems in children.
Most of my patients are severely constipated (constipation is what causes bedwetting and accidents, my area of specialty), and most take Miralax, as an adjunct to other treatments. So their parents are, understandably, alarmed when they hear — via TV or newspaper — that Miralax has triggered rage, aggression, phobias, anxieties, and mood swings in children who have taken this popular laxative.
In a TV interview, one member of the Parents Against Miralax Facebook group said the makers of Miralax are "poisoning our children.”
Here's what I think: Miralax and its generic equivalents are generally safe, but there are alternatives, such as lactulose and magnesium citrate, that work well for most kids and pose no safety concerns in recommended doses. Parents worried about Miralax need not give it to their children. Period.
I remain open to the possibility that Miralax may trigger psychiatric symptoms in a small minority of children. Some parents in our Facebook support group have reported bad reactions — "profound psychological/social-emotional changes," as one mom described her son's response. And I continue to look for possible connections between Miralax and neuropsychiatric symptoms in my patients.
However, at this point my primary concern about Miralax is not that the drug is poisonous; my concern is that physicians over-rely on it to treat chronic constipation.
Countless children who take Miralax actually need far more aggressive treatment for constipation, a stubborn, misunderstood condition with a high recurrence rate. Simply softening a child’s stool, which is what Miralax accomplishes, will not necessarily fix the problem.
What’s more, because Miralax is so convenient to use and so effective at softening stool, our nation’s childhood constipation epidemic remains unexamined, along with the cultural forces driving it. Few are pausing to say: Wait, why do so many of our kids need laxatives in the first place?
But I digress! Let’s first return to the safety issue.
Currently, Children’s Hospital of Philadelphia (CHOP) is investigating whether PEG 3350, Miralax’s active ingredient, causes psychiatric symptoms in children. I eagerly await the results of this study, which was commissioned by the U.S. Food and Drug Administration.
When announcing the CHOP study back in 2015, the FDA revealed that routine testing of Miralax in 2008 showed trace amounts of ethylene glycol and diethylene glycol, chemicals found in antifreeze, in eight batches of Miralax. The FDA said these impurities resulted from the manufacturing process, and the amounts were so low that they complied with recognized safety standards. Furthermore, these chemicals were not found when batches from five PEG 3350 manufacturers were tested in 2013.
Certainly, it’s wise to investigate whether PEG 3350 causes psychiatric symptoms in children. However, at this point the scientific evidence connecting Miralax with psychiatric symptoms remains underwhelming.
As I detail in It’s No Accident, more than 100 studies have found PEG 3350 is safe to use in children, and zero published studies have linked Miralax to severe or harmful side effects, psychiatric or otherwise. The most common side effects, detailed in this 2016 review article, are flatulence, abdominal pain, nausea, diarrhea, and headache.
Miralax is an osmotic laxative, which means it draws water into the intestines, softening stool. The intestines are designed for absorption, somewhat like a filter, so the fear with any ingested drug is how much gets absorbed and how that absorbed drug may affect the body. But studies conducted on children and toddlers indicate PEG 3350 does not enter the child’s bloodstream; it just washes out the colon. What’s more, PEG 3350 appears to have no effect on the body’s balance of electrolytes (potassium, sodium, and other substances essential for the body to function).
That's why you can safely use Miralax for occasional high-dose clean-outs. I do not recommend using magnesium citrate for this purpose, because taking too much can harm the nervous system and cardiovascular system. How much magnesium citrate is too much in children? Nobody knows, so I strongly advocate sticking to the daily dose recommended on the packaging.
Media reports make much of the fact that Miralax is not approved by the FDA for use in children. A Philadelphia TV reporter acted as if her news organization was the first to unearth this information, telling her audience: “Action News has learned this medication is being regularly prescribed off label to infants and toddlers, when it's not recommended for use to anyone under 17.”
This is a bit like saying, “Action News has learned that many teenagers smoke pot.” True, yes, but not exactly a scoop!
I discuss this issue at length in It’s No Accident. In short: PEG 3350 was approved by the FDA for adults in 1999, is available over the counter, and is already taken by children all over the world every day. So the manufacturer, Bayer, has no incentive to fund the very complex, lengthy, and expensive process that would be required to petition for the drug’s approval in children.
Once the FDA approves a drug for any indicated use, physicians may legally prescribe the drug for patients in other age groups. That’s called off-label use, and it’s common practice. In fact, here’s a statistic that may surprise you: Nearly 80 percent of children receive off-label medications during hospitalizations.
Only a small number of drugs have been formally tested in children. Because PEG 3350 is actually one of them and because thousands of my patients have taken this drug without incident, I do not worry that it’s toxic.
Osmotic laxatives, by the way, are different from stimulant laxatives, such as Ex-Lax, which prompt the intestinal muscles to contract and squeeze out the idle poop. Stimulant laxatives have their place, but children can become dependent on them, so in children stimulant laxatives should be used sparingly.
Miralax, on the other hand, is not habit forming — well, at least among people who take it. It's doctors who have developed a bad Miralax habit. The parents interviewed by the Philadelphia TV station said pediatricians “prescribe it like water.” I agree.
Where Miralax Falls Short
The Western world has a large-scale childhood constipation problem due to 1.) our highly processed diet, 2.) our rush to potty train, and 3.) the restrictive bathroom policies in K-12 schools. But Miralax is not the solution to the havoc wreaked on our kids’ insides.
Constipation is the top cause of abdominal pain among kids, the cause of virtually all bedwetting and daytime pee accidents, the major cause of recurrent urinary tract infections in girls, and basically the only cause of encopresis (poop accidents).
Withholding poop is a bigger deal for children than most folks realize. Pretty quickly, stool piles up and hardens in the rectum, which happens to reside very close to the bladder. To accommodate the large poop mass, the rectum stretches, encroaching upon and aggravating the bladder. Many of my patients have such large poop masses — think softball or grapefruit — that their bladders are practically flattened. You should see the X-rays! In many of these kids, the rectum has been stretched for so many years that it has lost tone and sensation; poop just falls out of their bottoms, and the kids can’t feel it.
And yet, prior to landing in my clinic, most of these kids were prescribed . . . Miralax.
And when Miralax failed to resolve the problem, these kids were prescribed . . . more Miralax. And then more!
No question: Miralax does a good job of softening moderately hard poop. But using it to break up and dislodge the kind of stool masses that cause bedwetting and accidents? That’s like expecting a trickle of water to clean a dish encrusted with week-old refried beans.
It doesn’t work!
What does work: the Modified O'Regan Protocol (M.O.P.), a regimen that involves daily enemas until dryness is achieved (and at least 30 days) and then tapering to every other day and then twice a week. This is the treatment pioneered by Dr. Sean O’Regan back in the 1980s; his research proves it works. (And yes, it’s safe.) Miralax wasn’t available in Dr. O’Regan’s day, but my own published research comparing enemas to Miralax confirms enemas are far more effective. Every day, my clinical experience reinforces this finding.
As I explain in The M.O.P. Book, while Miralax can soften stool, the soft stuff often just oozes around the hardened mass. The child appears to be pooping more, but nothing inside has changed. Many doctors focus on how often a child poops; if the child is pooping daily, they’ll declare constipation cured, even if the child is still having accidents or painful stomach aches. Fact is, many constipated kids poop two or three times a day — they just don’t fully empty. In these kids, Miralax can make things worse, triggering poop accidents that weren’t even happening before.
If enemas work so much better, why do doctors keep prescribing Miralax?
Many don’t realize how constipated these children are and figure Miralax will do the trick. I used to be among these doctors, so I get it. But now I X-ray my patients (yes, that’s safe, too), so I know better.
Other doctors do realize how badly constipated their patients are, but they’ve decided — without evidence or experience — that enemas are “traumatizing” and “dangerous” and prefer to prescribe higher doses of Miralax (sometimes in conjunction with Ex-Lax).
Do you know what’s traumatizing? Having poop accidents in first grade and wetting the bed in high school. I have countless patients who endured daily accidents because their constipation was never properly treated. They were told they would just “outgrow” the problem or were given endless doses of Miralax.
These kids have not been “emotionally scarred” by enemas; they have been able to enjoy childhood again. As the members of my Facebook support group can attest, enemas quickly become routine for kids. Many kids feel so much better after getting a real cleanout that they actually request their nightly enemas.
Alternatives to Miralax
And yet, I do often prescribe Miralax, or any osmotic laxative of the parent’s choice.
Over the years I have made slight adjustments to Dr. O’Regan’s enema regimen; one of these is the addition of a daily osmotic laxative. Whereas enemas do a superior job of cleaning out the rectum, Miralax keeps stool mushy. These are two different jobs. Children on (M.O.P.) should poop daily on their own, not just right after the enema, and the poop should come out like soft-serve ice cream. That’s where laxatives help. I’ve seen more success with osmotic laxatives plus enemas than with enemas alone.
Most parents I work with choose Miralax as their osmotic laxative, because it’s readily available, easy to use, and has no taste. But plenty of families won’t touch Miralax with a 10-foot pole, and that is fine with me. Many prefer lactulose, a sweet, prescription liquid that contains two sugars. Other families swear by magnesium citrate, the ingredient in Natural Calm. While the taste turns off many kids, others like it. Some of my patients take Pedia-Lax chewable tablets, which contain magnesium hydroxide, also known as milk of magnesia.
These are all good options, too, for children who are constipated but not so severely that they are having accidents. However, some of these kids could also benefit from more aggressive treatments, including solid or liquid glycerin suppositories or the occasional pediatric enema.
Of course, a child’s diet matters a lot. Lisa Leake of the 100 Days of Real Food book and blog, reports that her daughter completely overcame constipation after cutting out all processed food. I believe it! Some children become constipated when they consume dairy or other foods, so that may be something to experiment with. (However, as I explain to my patients, once a child is constipated to the point of having accidents, dietary changes won’t suffice.)
Exercise and drinking a lot of water help, too. So does peeing every few hours and sitting on the toilet to poop at least once a day, ideally after eating and always with feet planted on a tall stool.
By the time most folks recognize a child is constipated, chances are the child’s pipes have been clogged for many months, if not years. It takes a lot more than Miralax to fix this situation. At any rate, while we await a research-based verdict on this stuff, no parents should feel compelled to give their child Miralax at all.