MiraLAX was initially approved by the FDA as a prescription drug laxative medicine.
In 2006 the FDA approved “over-the-counter use of MiraLAX (polyethylene glycol 3350) powder for solution for the treatment of occasional constipation (irregularity)”.
Despite the fact that MiraLAX is not intended for use by young children, pediatricians and other doctors have been prescribing or recommending MiraLAX use in that patient population for many years, apparently. Generally, this use of MiraLAX by children pursuant to their doctor’s guidance is called “off-label” use.
About 15 years to the day after MiraLAX was approved, and following many significant adverse events reports concerning children having been submitted to the FDA, it was finally decided that there should be a medical study done on the use of MiraLAX by young children.
This medical study, “The Use of Polyethylene Glycol in the Pediatric Population”, is currently underway at the Children’s Hospital of Philadelphia (CHOP).
What is remarkable, and sad, about the reason the FDA finally saw fit to establish and fund this investigative study of MiraLAX off-label use by children is presented in this February 14, 2017 report by Wendy Saltzman, of WPVI-TV in Philadelphia, “Action News Investigation: Parents Say Over-the-counter Medicine Sickening Kids”.
We get the following disturbing anecdotal reports of MiraLAX adverse reactions in children from the first part of that posted article by reporter Wendy Saltzman:
“We saw a lot of the anger, a lot of the rage, a lot of the aggression,” parent Mike Kohler said.
“Near psychiatric events with paranoia, mood swings, aggression, rage,” parent Jeanie Ward said.
“I feel like my son was absolutely robbed of most of his childhood,” parent Jessica Aman of Chester Springs, Pa. said.
“He had the rage, fears, phobias, anxieties,” parent Sarah Locatelli said.
Jeanie Ward’s daughter Nicole was placed on MiraLAX when she was just 3 1/2-years-old. Within ten days, she says Nicole turned manic, aggressive, and paranoid.
“It was horrifying to see my daughter change like that and to not come completely go back to normal,” Ward said.
We will be looking further into this possible drug-safety problem involving children who used MiraLAX and developed neurological side effects and/or significant psychiatric problems.