The next day I went to the drugstore to pick it up and I was surprised when I saw the active ingredient: polyethylene glycol 3350. Polyethylene glycol? Yikes! I put the product back on the shelf and decided to do some research.
So, What is Polyethylene Glycol Anyway?
Dow Chemical's Polyethylene Glycol (PEG) chemicals "are water-soluble linear polymers formed by the addition reaction of ethylene oxide to an ethylene glycol equivalent. Sometimes referred to as polyglycols or polyols, their properties make them among the most versatile chemical ingredients and processing aids available to formulators and manufacturers of a wide range of products." It's been about 30 years since I took a chemistry class so I won't embarrass myself by trying to explain what exactly that means, but I can tell you that PEG works to alleviate constipation by drawing water into the colon to stimulate a bowel movement.
In addition to laxatives, PEG is used in a wide range of products indeed. Below are a few:
- Agricultural chemicals
- Disinfectants (nonagricultural)
- Hairspray (non-aerosol)
- Herbicides for agricultural, garden and health service use
- Household dry automatic dishwashing detergents
- Laundry starch preparations
- Lubricating oils
- Other hair preparations, including heat setting wave solutions
- Other pharmaceutical preparations acting on the skin
- Pet flea and tick products, including collars
- Pharmaceuticals for veterinary use
- Eye drops
- Skin cream
- Rocket fuel
- Paintballs
Pediatric Constipation
As unpleasant as it is to discuss, constipated kids are common and the problems can be significant. A 2009 study reported an 8.9% worldwide prevalence in "functional constipation" (that is, chronic constipation with no known physical cause). Chronic symptoms are a source of great distress to children and their families, more behavioral problems are reported in these kids, and quality of life is negatively affected as well. In up to one third of children suffering with functional chronic constipation, symptoms persist into adulthood. Potty training is a common time for constipation to start, as children find themselves in a "test of wills" with their parents.
Laxative Sales
The Consumer Healthcare Products Commission reports that over the counter laxatives are a $1.3 billion dollar a year industry (2013). Bayer's MiraLAX products make about $180 million for the company per year. I was unable to find any figures showing how much of the market is driven by pediatric sales, but a New York Times article reports that a 2006 peer-reviewed study found 75 percent of about 350 pediatricians nationwide had suggested parents use MiraLAX or similar generics to treat childhood constipation.
MiraLAX: Safe for Children?
Polyethylene glycol is generally considered to be a low toxicity agent and no studies have shown severe side effects, though there are concerns about organ system toxicity (i.e., toxicity linked one or more biological systems in the body through laboratory studies or studies of people). That being said, no studies have ever been conducted on children. Why is this? Because the drug is approved only for adults and only for seven days at a time. If you look at the product label above, note that for "children 16 years of age or under: ask a doctor." These so-called off-label uses of drugs in which a physician recommends or prescribes a medication not approved for a particular use or age group are common and perfectly legal. The Food and Drug Administration (FDA) regulates labels, not prescribers.
But in 2009, the FDA took the issue of potential side effects of these products seriously enough to discuss it at its Drug Safety Oversight Board Meeting. Below is an excerpt from the agency's report:
The FDA also wrote "There is a perception that PEG is safe because it is minimally absorbed from the stomach and intestines. However, little is known about whether absorption in children differs from adults, especially in children who are constipated, have underlying intestinal disease, or are very young." In 2011 the agency listed polyethylene glycol on its Adverse Event Reporting System (AERS) to monitor "neuropsychiatric events," which means that the agency has identified a potential safety risk, but ultimately the FDA decided that because there is no evidence of severe side effects, no action would be taken.
There is also a vocal online community of parents complaining about side effects of MiraLAX. And this guy, who blames MiraLAX for a host of serious medical issues (but he also sells alternative competing products, so take it with a grain of salt. Or, if you're constipated, take it with a teaspoon of epsom salt as that is known to be a natural remedy.)
Outcomes (No Pun Intended)
I don't know what the answer is here. For me, the lack of research and potential for harm is enough to keep me away from this product. That being said, every parent does a cost/benefit analysis whenever they give their child anything to ingest. For your child, the benefits may outweigh the potential costs. The only advice I can give with certainty is read labels, ask questions, and do your homework!
I'm happy to say that after a couple months, my son became acclimated to the new routine and is now doing just fine without the use of medication. Initially, I stocked up on any sort of natural remedy I could find, like prune juice and probiotics. But I think what he really needed was time and patience.
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