FDA-Funded Study About The Use Of Polyethylene Glycol In The Pediatric Population Currently Underway At Children's Hospital Of Philadelphia
(Posted by Tom Lamb at DrugInjuryWatch.com)
MiraLAX is a popular over-the-counter laxative medicine from Bayer Healthcare LLC. Its active ingredient is Polyethylene Glycol 3350.
MiraLAX was initially approved by the FDA as a prescription drug on February 18, 1999.
From the DIRECTIONS section of the MiraLAX® Drug Facts part of the packaging (viewed 5/4/17) we get the following relevant information:
Do not take more than directed unless advised by your doctor.
… Adults and children 17 years of age and older:
- fill to top of white section in cap which is marked to indicate the correct dose (17 g)
stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature), then drink- use once a day
- use no more than 7 days
Children 16 years of age or under: ask a doctor.
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.
Detailed information about this medical study, "The Use of Polyethylene Glycol in the Pediatric Population", can be found in this U.S. Department of Health and Human Services document, posted on January 14, 2014 by the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER).
This MiraLAX medical study 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".
This February ABC TV news report contains several stories of children who developed neuro-psychiatric problems after taking MiraLAX, according to their parents. An accompanying article posted on the WPVI-TV website includes these supplemental sections: FDA Response; Children's Hospital of Philadelphia Response; and, Bayer Response.
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.
"[Neuro-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.
For that purpose, we encourage anyone with relevant information, such as parents and medical researchers, to share it with us by leaving a Comment using the form below.
P.S. In an October 6, 2006 letter to Braintree Laboratories, Inc. the FDA approved "over-the-counter use of MiraLAX (polyethylene glycol 3350) powder for solution for the treatment of occasional constipation (irregularity)".
Interestingly, at page 2 of this October 2006 letter about MiraLAX going from a prescription drug to over-the-counter (OTC), we found this excerpt pertaining to pediatric patients MiraLAX treatment:
Your deferred pediatric studies required under section 2 of the Pediatric Research Equity Act (PREA) are considered required postmarketing study commitments. The status of these postmarketing studies shall be reported annually according to 21 CFR 314.81. This commitment is listed below.
1. Deferred pediatric study under PREA for the treatment of occasional constipation (irregularity) in pediatric patients less than or equal to 16 years of age.
Final Report Submission: October 6, 2016.
Submit final study reports to this NDA. For administrative purposes, all submissions related to this/these pediatric postmarketing study commitment(s) must be clearly designated “Required Pediatric Study Commitments”.
We do not know anything at this time about what. if any, pediatric studies were done by Braintree Laboratories or Bayer Healthcare after this October 2006 was issued by the FDA.
If you know something, please considering sharing it by leaving a Comment using the form below.
(5/5/17)
DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects (All website content by attorney Tom Lamb)
Drug Injury Case Evaluation - Free. Confidential. No Obligation. (Case review done by attorney Tom Lamb)
Leave a Reply to Jennifer Kennett Cancel reply