Miralax is advertised as natural. It’s described as a tool to pull water into your colon so your gut can eliminate naturally. But there’s nothing natural about Miralax, as its active ingredient polyethylene glycol is a petroleum derivative. In essence, it’s plastic.
What’s more, Miralax is not approved for use in children. The US Food and Drug Administration (FDA) has only approved it for adult usage and even then only for seven days at a time. If your pediatrician or doctor has recommended Miralax for your child you better ask why? Even the slow moving FDA has said NO to children in 2008.
No one knows what for sure what happens when children take PEG laxatives chronically, but a growing number of adverse events are being reported, including concerning neurological disturbances, kidney problems and more. With scrutiny increasing, and a new study into their side effects underway, it’s time to think twice before turning to laxatives for constipation.
Laxatives with the active ingredient polyethylene glycol 3350 (PEG 3350), the most popular of which is Miralax, are commonly given to children with constipation. Some of these children end up using the drug daily for years, which their parents (and likely their doctors as well) probably assume is safe.
FDA Study Detected Antifreeze Chemicals in Laxatives
In 2008, the FDA tested eight batches of Miralax because “many of the reported adverse events were classic symptoms of ethylene glycol ingestion.”4 Ethylene glycol (EG) and diethylene glycol (DEG) are ingredients in antifreeze so, in other words, the government tested the laxative after receiving reports of children exhibiting symptoms of antifreeze poisoning following their use.
The study “confirmed the presence of small amounts of ethylene glycol and diethylene glycol in all lots tested,”5 with the FDA describing them as impurities resulting from the manufacturing process. Those results were not released and only came to light after being “buried in the agency’s brief to researchers, issued last year .”6 Yet, in 2009 the FDA’s drug safety oversight board raised several concerns about the use of these laxatives in children.7
They noted that children may be more susceptible to variations in PEG product quality and effects of large doses of PEG given for weeks or longer is not known. They also stated that “it is unknown if prolonged duration in solution would change the chemical properties of PEG-3350,” or, in other words, what might happen when the substances are ingested and/or metabolized.
In addition to finding EG and DEG in the products, PEG may be breaking down into EG and DEG in your body (polyethylene glycol is a chain of EG molecules).
So ask yourself again, why is someone recommending this for my children?
Thousands of Neurological Adverse Events Reported
There have been more than 7,000 reports related to PEG laxatives filed in the FDA’s Adverse Event Reporting System (FAERS), according to Carol Chittenden, co-director of the Empire State Consumer Project, an advocacy group. This is likely an underestimate of the true problem, as for every adverse event that’s reported, there may be 100 more that are not reported.
Following thousands of complaints from parents, many of them in discussion groups online, the Empire State Consumer Project petitioned the FDA to investigate the safety of PEG 3350 in 2012. Part of the petition called for the FDA to add a boxed warning about children on PEG 3350 laxatives, which the FDA has not acted on.
However, in September 2014 the FDA awarded a nearly $325,000 grant The Children’s Hospital of Philadelphia to study whether PEG 3350 is absorbed by the very young and whether it contributes to the development of psychiatric problems. Among the adverse events reported, many of them are neurological in nature. According to the FDA:8
“Neuropsychiatric adverse events [in children using PEG products] may include seizures, tremors, tics, headache, anxiety, lethargy, sedation, aggression, rages, obsessive-compulsive behaviors including repetitive chewing and sucking, paranoia, and mood swings.”
There were also reports of metabolic acidosis, which is a disturbance in the body’s acid-base balance, leading to too much acid in your blood. While some cases of metabolic acidosis are mild others can lead to shock or even death. Poisoning resulting from ethylene glycol from antifreeze produces many of these same symptoms, including metabolic acidosis and neurologic effects.
If you or your child has experienced any adverse events while taking a PEG 3350 laxatives like Miralax, please report them – both to your physician and directly to the FDA’s Adverse Event Reporting System.
So why is someone prescribing Miralax for my child with an outrageously high number of seizures and tremors, aggression and other neurological problems.
PEG Laxatives Are Also Prescribed for Colon Prep Prior to Colonoscopy
Even if you’re not constipated, you may have taken PEG 3350 if you’ve had a colonoscopy screening. The laxative is commonly included as part of the preparation. Any PEG 3550 effects will, in this case, be limited to just one exposure, albeit a large one, unlike in the children that take this laxative chronically.
However, if you’re planning to schedule a colonoscopy and want a truly safe, non-toxic alternative, talk with your physician about using magnesium citrate only. The only side effect of magnesium citrate is loose stools, which is why it’s a non-toxic alternative for colonoscopy prep.
In addition, some practitioners are having a lot of success using colon hydrotherapy as a prep just prior to the colonoscopy. Unfortunately, at this time this is not widely available. Remember that your only option for colon prep is not to simply take the potentially toxic PEG 3550 laxatives.
If your physician is not willing to offer you an alternative, then seek out a physician who will.
Health and Wellness Associates