For many parents, constipation is a regular challenge for their children and it’s one of the common medical issues associated with autism. While this is not something we’ve dealt with too often, I understand the frustration and anguish as parents watch their kids writhe in pain because they simply cannot poop.
To deal with this problem, many doctors are prescribing MiraLAX as a remedy and I have heard parents actually claim that they have used this treatment for a year or two on their child.
Too MUCH MiraLAX brings with it inherent risks and I’m sharing this article about the dangers of MiraLAX and what other options parents have.
Additionally, using a laxative isn’t solving the problem; it’s just relieving symptoms. In fact, this story won’t go away!
Why MiraLAX is Under Fire
In January 2015, the NY Times (NYT) reported on the validity of using laxatives as a childhood remedy. The article reports that “doctors have long recommended these laxatives for their convenience and on the grounds that very little PEG 3350 (the active chemical in MiraLAX) is absorbed in the intestines.” At the time, the FDA claimed there was not enough data about the effect of this chemical in children.
In 2016, the FDA investigated the prolonged use of MiraLAX on children.
“FDA decided that no action is necessary at this time based on available information” for PEG 3350. However, given the track record of the FDA, I would myself say, “Let me see the evidence.”
More Recent Trouble for MiraLAX
Since the 2015 report, you might have thought this all settled down.
- May 2018: There was ANOTHER headline about this toxic chemical. This NBC News article is reporting on it, the headline reads, “Parents warn popular over-the-counter medication sickened their kids.” Pretty damning, isn’t it? What’s interesting is that the article has science in it which “proves” it’s safe for children.Tell that to the mom whose child was on increasing doses of this drug from ages 1 through 6. After the girl had a hospital stay, they stopped the MiraLAX.
The child suffered tics and aggression and within 30 days, those behaviors were GONE. Read MORE stories in the article and learn about the FDA’s study.
- October 2017: Read this doctor’s editorial on why the science is lacking and we can’t be sure at this time if MiraLAX is safe for children.
A Group of Families Comes Forward
6ABC News reported this week that an over the counter medication is getting kids sick. “A group of families approached Action News with disturbing claims that children have developed neuro-psychiatric problems after taking MiraLAX.”
Problematic Symptoms of MiraLAX Reported
Parents have reported anger, rage, aggression, anxiety, paranoia, mood swings. In response, Children’s Hospital of Philadelphia (CHOP) just conducted $325,000 of research on one of the main ingredients of MiraLAX, PEG 3350.
At that time the Food & Drug Administration (FDA) reportedly told Action News, “there was “insufficient data to demonstrate a link between PEG 3350 and serious neuropsychiatric issues in children.”
They cited only 167 adverse events reported to the FDA through 2012. Unfortunately, the reporters found a LOT more than that. They discovered 5x as many in the reports they searched.
More Families Speak Out About MiraLAX
After the initial report on 2/15/17, more families reached out to 6ABC News. “Lots of parents have reached out to us asking what to do, desperate for answers because some say after their children were prescribed MiraLAX off-label, the behavioral issues started – from depression to anger, anxiety and mood swings.”
In fact, this garnered so much attention that the FDA responded. Additionally, the report links to the CHOP study.
FDA, CHOP and Doctor Feedback Over MiraLAX
The FDA is continuing their study. This article lists the details of the study, which is being conducted at the Children’s Hospital of Philadelphia. Meanwhile, outraged parents have formed a Facebook support group. This article is worth a read for some of the stunning comments made by William T. Gerson, MD:
“One needs to remember that, unfortunately, children can rarely have the sudden onset of disturbing symptoms,” Gerson said. “Given the common use of MiraLAX, chance association is likely to occur; that by no means is meant to infer that there are not rare complications or that the use of MiraLAX is appropriate in all situations. However, there are no data to support a change in practice at this time and alternative treatments are not necessarily safer.”
This Sounds Familiar…
This sounds an awful lot like the initial response to mitochondrial disease or PANDAS, “It doesn’t exist.” “The symptoms are not a sign of a health issue.”
It also sounds like tobacco science: “We’ll keep using what is not recommended (longterm use of MiraLAX, use of MiraLAX for children) until we conclusively have evidence beyond your stories, Mom.”
Is MiraLAX causing behavioral problems in children? Another mom shares her story.
Yet another article, this one from December 2017:
- Bayer reiterates that the usage time on the label is 7 days; anyone prescribing it for longterm use is NOT them, but a physician.
- David Rosenberg, Chair of Psychiatry at WSU & Children’s Hospital of Michigan says that “often children with digestive issues also have psychiatric issues.”Instead of docs just prescribing away (opioids, anyone?), maybe they should get educated on the human microbiome and find out why these things are happening to kids. Relieving symptoms without knowing what’s going on does very little to help a body.
More Reports of Harm
The study came about in some part because of the reports the FDA has received complaining of seizures, tremors, tics, headache, anxiety, lethargy, sedation, aggression, rages, obsessive-compulsive behaviors including repetitive chewing and sucking, paranoia and mood swings. Unfortunately, this page has been removed from the FDA website.
You can read more about parental concerns about the dangers of MiraLAX on this NYT article, “Drug for Adults is Popular as Children’s Remedy.”
In addition, MiraLAX was never approved by the FDA for use in children. The current studies that show no dangerous adverse effects have not been adjusted for children, so there is no way to know if it can be causing damage. Meanwhile, another news story surfaced in June 2015.
Law360.com reports that a Pennsylvania man who took MiraLAX for 4 years under a physician’s supervision sued Bayer for kidney damage, citing PEG 3350 as the cause.
The Dangers of MiraLAX & the Experts
What do the experts say about the dangers of MiraLAX?
We’re Over-Constipated as a Culture
Over at Parents.com, Steve J. Hodges, M.D., associate professor of pediatric urology at Wake Forest University School of Medicine in Winston-Salem, North Carolina who widely prescribed this laxative to his patients defended his position.
What’s interesting about the article is the prevalence of constipation in the Western world – he calls it an epidemic – and the causes: too many processed foods, too-early potty training, kids “holding it in.” I feel like this doctor has left out way too many causes of constipation.
Remember too, that in this article, Hodges is defending his prescribing and that it’s the FDA – hardly the most caring of organizations – that has put MiraLAX on the firing line. In fact, some doctors recommend parents to “develop an exit strategy” to get off of MiraLAX.
PEG 3350 is “Safe”
So what is in MiraLAX and other laxatives? PEG 3350 is short for Polyethylene Glycol 3350. Autism Speaks reports that the FDA found trace amounts of ethylene glycol and diethylene glycol when studying these laxatives while the FDA claims these are toxic only in large amounts.
Note that both of these chemicals are in antifreeze, but I don’t know if the chemical composition may be different in MiraLAX. The problem for me with “trace amounts” is that we’re not sure what other products our kids are exposed to that also have trace amounts.
In addition, while most doctors and experts agree that trace amounts of chemicals safely leave the body, kids with autism have difficultly methylating and detoxing their systems the way that people without autism do. That would make me very nervous, and it’s part of why I keep my daughter to only natural remedies and additive-free foods.
PEG 3350 May Be Habit Forming – MiraLAX Isn’t
So I found several articles that said ONE thing, and several that said the other. The question: is MiraLAX habit forming? One article I found linked to a PDF of the MiraLAX label, but it did not claim to be habit forming, however, it did say to check with your doctor after 7 days if you have no relief. Seven days…and some people are taking it for years and years. MedLinePlus claims that PEG 3350 “may be habit-forming,”
I’ve seen so many back and forth arguments about the dangers of MiraLAX, including the argument that since a child’s colon is not doing its job, the question of overusing this laxative is moot. That, however, is a circumvention of the real problem. Like so many over the counter drugs, MiraLAX is merely treating a symptom and not removing the cause of constipation.
If you need solutions on what to instead of Miralax, read part 2 of this article.
Disclaimer: I’m not a trained medical provider. You should always check with your healthcare provider when you are changing care for your child or considering treatments.