![]() 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. "The (FDA) has conducted a review that documented a number of reports of neurological and psychiatric events associated with chronic PEG use in children. "The Food and Drug Administration has received a number of reports of adverse events in children taking PEG products," the grant notice states. However, the federal government suggested not enough is known about the effects of PEG 3350 in children. "While MiraLAX is not labeled for use in the pediatric population, there have been many clinical studies conducted with PEG 3350 in pediatric populations, which have demonstrated safety for short- and long-term use in children with a history of chronic constipation," the company wrote in a statement to News 6. The manufacturer of MiraLAX, Bayer, acknowledges that the laxative is not recommended for children but believes it is safe. The agency never approved long-term daily use of the laxatives, even in adults. The New York Times reported on PEG 3350 in January 2015, saying MiraLAX and similar laxatives have been recommended by doctors for their convenience and on the grounds that very little PEG 3350 is absorbed in the intestines.īut there is not much data detailing how PEG 3350 is absorbed in children, the FDA said, especially those who are very young and chronically constipated. So, without FDA approval, why is MiraLAX being recommended for people younger than 17? "Use in children less than 17 and chronic use is not approved by the FDA, but nevertheless, the laxative is used as such in clinical practice." "Polyethylene glycol laxative is approved for over-the-counter use for occasional constipation in adults and children 17 years of age and is recommended for short-term use up to seven days," the notice says. You can read background information and details about what the study hopes to find in the link above. Until the study is complete, the hospital won’t comment on specific cases or any findings.Ī grant notice is an official document that lets whoever requested the grant know that the project was approved and the funding will be made available. “Researchers in (the hospital’s) Division of Gastroenterology who will be conducting the study have not begun enrolling children, but once enrollment begins, an announcement will be made,” read a statement from the pediatric hospital. Food and Drug Administration awarded a $325,000 grant to Children’s Hospital of Philadelphia to study polyethylene glycol 3350 (PEG 3350), the active ingredient in MiraLAX that increases the frequency of bowel movements and softens the stool. Parents also describe troubling side effects in their children, including anxiety, behavioral issues, speech problems and depression. Numerous parents reported that pediatricians are recommending adult-sized doses of the laxative for children as young as 9 months old, and in some cases, for extended periods of time. The online group had more than 18,000 members as of Wednesday. Many moms and dads have voiced their concerns about the laxative on a private Facebook page, Parents Against MiraLAX (PEG 3350). Koehler is among a growing number of parents who believe MiraLAX may be causing neurological and psychiatric health issues in children. We no longer have the rage, the defiance, the impulsiveness.” It’s like our son came back to us,” Koehler said. Koehler claimed the then 9-year-old’s problems vanished almost immediately after he stopped taking MiraLAX. “It took us a little bit to connect these dots.” “We finally realized once we would give him the MiraLAX, he would have seizures,” Koehler said. ![]() ![]() “He just wanted to be dead, and that was frightening.”Īround the same time, the father said his son was diagnosed with epilepsy and began suffering mild, non-convulsive seizures.ĭespite help from a psychiatrist and neurologist, Koehler said his son’s behavior and medical issues improved very little until the family began experimenting with his laxative doses. “There were times where he actually tried to jump off the second-story deck (of the house),” Koehler said. The child, who Koehler requested that News 6 not identify by name, became angry and dark. “He would stomp on his (soccer) teammates’ feet to the extent he’s making them cry.” He was punching kids for no apparent reason,” Koehler said. “He was on it for almost five years,” Koehler said.Īs his son entered third grade, the father said he noticed a troubling change in the boy’s behavior. When Mike Koehler’s son was 4 years old, a urologist diagnosed the child with chronic constipation and recommended daily doses of the over-the-counter laxative MiraLAX, according to the family.
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