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Is MiraLAX Safe for Young Children?

2:30

Constipation is a common problem in kids. It can become a painful elimination process if not treated quickly. Children will sometimes “hold” their poop to avoid the experience, making the situation worse.

Pediatricians often prescribe MiraLax for treatment. MiraLax contains PEG 3350, which is not habit-forming and is easy to give to kids because it has no taste or odor. You can mix it in their beverages, and they typically won't complain.

MiraLax is not a natural product. It does not completely clean a colon out, like an enema does, but it works well enough to unclog a child. Over time, constipation can cause other serious health consequences, so the condition needs to be treated promptly.

While the majority of children do fine when given MiraLax, a group of parents have reported dramatic changes in their child’s personality after being given the laxative.

For the past few years, the Children's Hospital of Philadelphia (CHOP) has quietly been conducting an FDA-grant funded study into parents' reports of devastating side effects from their kids' use of the over-the-counter constipation relief drug.  

But until that study is completed, the hospital won't comment on the experiences of individual families.

A FaceBook page called, Parents Against MiraLax (PEG 3350) has been created, and more than 3,500 people have joined to organize and voice concerns about PEG 3350.

When the FDA grant was awarded to CHOP in early 2014, the federal agency disclosed that MiraLAX powder contains small amounts of Polyethylene glycol 3350 (PEG 3350), which may under certain conditions degrade into ethylene glycol or diethylene glycol — toxic ingredients found in antifreeze.

"The Food and Drug Administration has received a number of reports of adverse events in children taking PEG products," the FDA said in its grant description. "The Agency has conducted a review that documented a number of reports of neurological and psychiatric events associated with chronic PEG use in children. A number of these pediatric patients received an adult dose of PEG (17 grams) for a duration ranging from a few days to a couple of years."

MiraLAX, manufactured by Bayer, is not recommended for patients under the age of 17, but the FDA concluded that it is often suggested to parents in clinical practice.

Bayer has responded in a statement, referencing existing clinical studies confirming the long and short-term safety of PEG 3350 in pediatric patients, though the company acknowledged the product is not labeled for use in the pediatric population.

An article in the New York Times, published in 2015, reported that the FDA had raised questions about the safety of an “an adult laxative routinely given to constipated children, “ sometimes for years.

The article also mentioned that buried in the FDA’s brief to researchers, it had tested eight batches of MiraLax and found tiny amounts of ethylene glycol (EG) and diethylene glycol (DEG), ingredients in antifreeze, in all of them. The agency said the toxins were impurities resulting from the manufacturing process.

Those tests were conducted in 2008, but the results were not disclosed. Jeff Ventura, an F.D.A. spokesman, said batches were tested because “many of the reported adverse events were classic symptoms of ethylene glycol ingestion.”

Psychiatric illnesses like those reported in children taking the laxatives have also been observed in cases in which a child took substantial amounts of ethylene glycol. Some children taking MiraLax chronically (over long periods of time) also have developed acidic blood, according to F.D.A. records, which can be a consequence of ingesting EG.

MiraLAX primarily is recommended for short-term use up to seven days to relieve constipation. The FDA does not approve chronic use, although many use it regularly or even daily to treat severe issues with digestion.

The North American Society of Pediatric Gastroenterology, Hepatology and Nutrition and the American Academy of Pediatrics said in statement after the study began, that they welcome “an investigation into the safety of treatment through data and research in the prolonged use of PEG 3350.”

A timeline for the CHOP study results is not immediately known.

For many children, MiraLax works well as a short-term laxative. However, parents should discuss the dosage and the pros and cons of giving it to the their child with their pediatrician.

Story sources: Michael Tanenbaum, http://www.phillyvoice.com/chop-leading-fda-study-parents-alarming-claims-about-over-counter-drug-miralax/

Catherine Saint Louis, https://www.nytimes.com/2015/01/06/science/scrutiny-for-a-childhood-remedy.html?_r=1

Steve Hodges, MD, http://www.parents.com/blogs/parents-perspective/2015/01/07/health/is-miralax-safe-for-kids-an-expert-weighs-in/

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