Hide this

Story at-a-glance -

  • Miralax and other laxatives with the active ingredient polyethylene glycol 3350 (PEG 3350) are commonly given to children even though they’re only approved for use in adults
  • More than 7,000 reports related to PEG laxatives have been filed in the FDA’s Adverse Event Reporting System (FAERS)
  • Adverse events include neurological problems, metabolic acidosis, and more
  • An FDA study detected small amounts of the antifreeze chemicals ethylene glycol (EG) and diethylene glycol (DEG) in PEG laxatives
 

Scrutiny for Laxatives as a Childhood Remedy

January 21, 2015 | 80,941 views
| Available in EspañolDisponible en Español

By Dr. Mercola

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.

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.

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.

Majority of US Pediatricians Have Recommended PEG Laxatives

If your child suffers from chronic constipation, there's a very good chance your pediatrician recommended Miralax (or a generic equivalent) as a safe solution. According to one study, 75 percent of pediatricians had used such laxatives to treat childhood constipation.1 One Beverly Hills, California pediatrician even told the New York Times:2

"'I've had kids on it daily for years" …For children with chronic constipation who are not being helped by dietary changes, "We literally give it like water.'"

Unfortunately, there is very little science on what happens when PEG 3350 is consumed and whether or not it is absorbed by children. According to the FDA:3

"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… Children are receiving adult doses of PEG in some cases."

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 [2014]."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).

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 ore your child has experienced any adverse events while taking a PEG 3350 laxative like Miralax, please report them – both to your physician and directly to the FDA's Adverse Event Reporting System.

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 laxative. If your physician is not willing to offer you an alternative, then seek out a more naturally oriented physician who will.

Natural Alternatives for Treating and Preventing Constipation


Constipation is defined as passing hard, dry stools that you have to strain to move, and it's typically accompanied by decreased frequency of defecation. Straining is not normal, nor are experiencing feelings of incomplete elimination, bloating, crampiness, or sluggishness after going number two. If you're over the age of 65, your risk of becoming constipated increases significantly. Chronic, untreated constipation can lead to fecal impaction, which can be a serious medical condition. Laxatives should be avoided at all cost and used only as a last resort, not only due to the potential side effects but also because your body may become dependent on them.

Laxatives may decrease your colon's ability to contract and can even eventually damage your large intestine's nerves, muscles, and other tissues. This applies to both pharmaceutical laxatives as well as herbs like cascara. If you absolutely must use a laxative, make sure it is used for only a very short period of time. Fortunately, although constipation is very common, it is also usually temporary and relatively easy to resolve – without resorting to laxatives. The strategies that follow will help reverse constipation in addition to helping prevent recurrences, and are safe for children and adults alike:

  • Remove all sources of gluten from your diet (the most common sources are wheat, barley, rye, spelt, and other grains)
  • Eat a diet that includes whole foods, rich in fresh, organic vegetables and fruits that provide good nutrients and fiber; most of your fiber should come from vegetables, not from grains
  • Avoid artificial sweeteners, excess sugar (especially fructose), chemical additives, MSG, excessive amounts of caffeine, and processed foods as they are all detrimental to your gastrointestinal (and immune) function
  • Boost your intestinal flora by adding naturally fermented foods into your diet, such as sauerkraut, pickles, and kefir (if you tolerate dairy). Add a probiotic supplement if you suspect you're not getting enough beneficial bacteria from your diet alone
  • Increase your fiber intake. Good options include psyllium and freshly ground organic flax seed (shoot for 35 grams of fiber per day)
  • Make sure you stay well hydrated with fresh, pure water
  • Get plenty of exercise daily
  • Avoid pharmaceutical drugs, such as pain killers like codeine or hydrocodone, which will slow your bowel function. Antidepressants, and antibiotics can cause a variety of GI disruptions
  • Address emotional challenges with tools like EFT
  • Consider squatting instead of sitting to move your bowels. Squatting straightens your rectum, relaxes your puborectalis muscle, and encourages the complete emptying of your bowel without straining, and has been scientifically shown to relieve constipation and hemorrhoids

Thank you! Your purchases help us support these charities and organizations.