For many parents of children suffering from constipation, the laxative MiraLax has been 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—though many doctors have been prescribing it off-label anyway, despite the fact that it's suspected to come with a whole bunch of scary side effects like behavioral issues, speech problems, anxiety, and depression.
Now several families are coming forward to claim their children have developed such neuro-psychiatric problems after taking MiraLax. The controversy kicked off 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 had 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."
So scary! Which is why Ward also helped author a petition to the FDA back in 2012 asking for a warning label and an investigation into MiraLax. An FDA grant was awarded to the Children's Hospital of Pennsylvania in 2014. So far, the study has found 167 cases of adverse side effects in children who took the laxative, including 37 kids who displayed neurological or psychiatric symptoms. And the FDA also disclosed that MiraLax powder was found to contain small amounts of the same toxic ingredients found in antifreeze.
Now parents like Ward—more than 13,000 and counting—are joining forces in a Facebook group called Parents Against Miralax in order to stop the recommendation of the medication (known generically as PEG 3350) to young children.
"We are a group of parents and family members who are highly suspicious of PEG 3350 and are here to discuss its cons," the group description reads. "We discuss alternative options and ways to talk to doctors about our opposition to this very dangerous drug."
For it's part, FDA told Action News that there is not sufficient data to link PEG 3350 to serious neuropsychiatric issues in children, or to warrant any additional warnings at this time. "However, because many parents and physicians rely on these products to treat serious constipation," the agency added, "we have decided to fund research to better determine the benefits and risks associated with the use of these products in children."
For now, that study is still ongoing, and the results will be disclosed to the FDA once they are released. But 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 two potentially toxic chemicals in batches of Miralax tested eight 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. Bunkin's sentiments echo that of Steve Hodges, M.D., who wrote a 2015 op-ed for Parents.com about the safety of MiraLax. "More than 100 studies have found PEG 3350 is safe to use in children, and I have found no published studies linking MiraLax to severe or harmful side effects," Dr. Hodges wrote. "Nonetheless, I welcome all inquiries into the safety of this ubiquitous laxative, and I look forward to the results of the government-funded study that will examine whether PEG 3350 may trigger psychiatric problems in children."