The over-the-counter constipation-relieving powder MiraLAX, made by Bayer, can “flip a switch” in the brains of otherwise happy children making them act out bouts of anger, aggression, rage and paranoia, a group of families claim. Their concerns, along with mounting adverse event reports reported to the Food and Drug Administration (FDA), have prompted Children’s Hospital of Philadelphia to launch a study to determine if these parents’ claims have merit.
After examining preliminary reserach, it appears the parents’ suspicions may have basis. The FDA stated that MiraLAX powder contains polyethylene glycol 3350 (PEG 3350), an ingredient that may degrade into two different toxic ingredients found in antifreeze, “and is known to be neurotoxic in children,” the Children’s Hospital study states in its study background report.
MiraLAX is approved for the treatment of constipation in adults and children 17 years of age and older for short-term use up to seven days. Use in children younger than 17 and chronic use is not recommended by the FDA, “but nevertheless the laxative is used as such in clinical practice,” the report states.
“The Food and Drug Administration has received a number of reports of adverse events in children taking PEG products. 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,” the report states.
A total of 167 adverse events in children who consumed MiraLAX have been reported to the FDA, 37 of which include neurological or psychiatric effects. Tests on some patients have shown “small amounts of ethylene glycol and diethylene glycol,” the same ingredients found in antifreeze.
While an investigation is underway, parents who gave their children MiraLAX on the advice of their doctors are reeling. Jeanie Ward said her child had “near psychiatric events with paranoia, mood swings, aggression, rage.” Jessica Aman says her son was robbed of most of his childhood after consuming the product and suffered rages, fears, phobias, and anxiety.
The families are part of a Facebook group, Parents Against MiraLAX, urging the FDA to add warnings to the label of the OTC constipation drug to warn of adverse events in children who were given the medicine.