If your child has ever suffered from constipation, you might have heard that the laxative Miralax is a godsend. It's shocking to learn, then, that the common over-the-counter medication is not meant to be used for kids under 17. There have even been reported side effects like behavioral issues, speech problems, anxiety, and depression. But the jury is still out among doctors if Miralax is safe for kids, with may still prescribing it off-label.
The controversy over Miralax began in February 2017 after 6 ABC Action News reported that Philadelphia mom Jeanie Ward gave her 3-and-a-half-year-old daughter Nicole the laxative on the advice of a doctor, and within 10 days, Nicole's personality changed drastically. "Near psychiatric events with paranoia, mood swings, aggression, rage," Ward explained. "It was horrifying to see my daughter change like that and to not completely go back to normal."
But doctors like Steve J. Hodges, M.D., associate professor of pediatric urology at Wake Forest University School of Medicine in Winston-Salem, North Carolina, have been prescribing Miralax, known generically as PEG 3350, to their adolescent patients for years.
"More than 100 studies have found PEG 3350 is safe to use in children," says Dr. Hodges. "Nonetheless, I welcome all inquiries into the safety of this ubiquitous laxative."
In 2012, Jeanie Ward helped author and direct a petition at the U.S. Food and Drug Administration asking for a warning label and an investigation into Miralax. And in 2014, an FDA-funded study by the Children's Hospital of Philadelphia (CHOP) began after the agency's own findings indicated "small amounts of ethylene glycol and diethylene glycol"—the same ingredients found in anti-freeze—in Miralax. So far, the study, which is still ongoing, has found 167 cases of adverse side effects in children who took the laxative, including 37 kids who displayed neurological or psychiatric symptoms.
As of April 2018, the FDA says the current labeling for PEG 3350 accurately conveys its risks, and no additional warnings about neuropsychiatric issues in children are needed at this time. "We look forward to results of the CHOP study, to further determine the benefits and risks associated with the use of these products in children," the agency said. The study's results will be disclosed to the FDA once they are released.
Experts like David Bunkin, M.D., assistant professor of pediatric gastroenterology and hepatology at Mount Sinai in New York City, remain hopeful that the CHOP study will eventually confirm the laxative's safety. He told Parents.com that while the FDA found trace amounts of those two potentially toxic chemicals in batches of Miralax tested years ago, ownership of the drug has since changed hands and follow-up screenings have not revealed the chemicals.
"This medication has been used safely for a long time in children without any known side effects and is a medication we routinely use in our pediatric gastrointestinal specialty office," Dr. Bunkin explained. "We continue to prescribe it in cases where diet changes to help constipation are not effective or possible, and feel that it is likely safe to use in children."
Dr. Hodges, for one, hopes the national conversation around Miralax will bring attention to the condition it aims to treat. Constipation is one of the most common causes of abdominal pain, bladder and kidney infections, enuresis ("bedwetting" accidents), and encopresis (involuntary defecation) for children, he says.
"In a small minority of cases, constipation has a medical explanation—a child may have Hirschsprung's disease or other rare, congenital conditions," he says. "But in 95 percent of cases, children withhold stool simply to avoid the pain of pooping. Stool piles up in the rectum, making bowel movements even larger, harder, and more painful."
As Dr. Hodges explains, young kids become constipated for several reasons: they eat too much processed food, they're potty trained before they're ready (and without adequate follow-up), and dismal public-school bathroom conditions and misguided restroom policies prompt children to steer clear of the toilet. "We as a society compound these problems by ignoring the early signs of constipation," he says. "No one bats an eye if a child has enormous or hard bowel movements (the top two signs of a clogged colon) or doesn't poop at least every other day. But children need to poop every day—soft, mushy poops."
If you're still feeling wary of dishing out even a small Miralax dosage, you may want to consider using an enema or physical therapy or try adding fiber-rich foods and prune juice to your child's diet to help move things along. (Do note: once constipation becomes severe, fiber and dietary changes are usually too little, too late.)
"Enemas have been proven in rigorous studies to resolve enuresis and encopresis, and yes, enemas are safe for children," says Dr. Hodges. "On the whole, my patients who receive enemas get far better results than those who use Miralax."
"Ultimately, it doesn't matter what method is used to empty a child's clogged rectum—as long as that method doesn't harm the child, of course," he concludes. "What does matter is that the child's bowels empty completely on daily basis, so the kid doesn't show up at the ER with painful urinary tract infections or opt out of sleep-away camp because she wets the bed."