An ongoing Children's Hospital of Philadelphia study is looking into parents' claims that their children developed "neuropsychiatric problems" after taking an over-the-counter laxative.
According to WPVI-TV, MiraLAX "is regularly prescribed off-label to infants and toddlers, when it's not recommended for use to anyone under 17."
Some parents said their children became angry, aggressive and paranoid after taking the medication, WPVI reported Tuesday.
Jeanie Ward told the station that her daughter, Nicole, began experiencing "near psychiatric events" and mood swings soon after she started taking MiraLAX at 3 1/2 years old.
"It was horrifying to see my daughter change like that and to not completely go back to normal," Ward told WPVI.
Jessica Aman of Chester Springs, Pennsylvania, echoed the sentiment, telling WPVI that her son "was absolutely robbed of most of his childhood."
Ward helped to petition the Food and Drug Administration for a warning label and investigation, which prompted the CHOP study of MiraLAX's active ingredient, polyethylene glycol 3350.
Although the study is still underway, the FDA told WPVI that there isn't enough data "to demonstrate a link between PEG 3350 and serious neuropsychiatric issues in children."
Bayer, MiraLAX's manufacturer, said in part: "As part of Bayer's ongoing commitment to consumer well-being, we regularly track, analyze and report all adverse event data related to the use of the product. Results of this ongoing monitoring support the continued safe use of MiraLAX."
In a 2015 article on Parents.com, Dr. Steve J. Hodges, an associate professor of pediatric urology at the Wake Forest School of Medicine, pointed out that "more than 100 studies have found PEG 3350 is safe to use in children."
"I have found no published studies linking MiraLAX to severe or harmful side-effects," said Hodges, who was responding to a New York Times article about the Philadelphia study.
Hodges added that he welcomes "all inquiries into the safety of this ubiquitous laxative" and looks forward to learning the study's findings.
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