Lorrin Scalise, a regular contributor to consumer and personal injury law firm websites and blogs, summarizes the recent news stories regarding the alleged dangers of MiraLAX usage in children under the age of 17. Specifically, the active ingredient in the product, polyethylene glycol 3350, is the subject of recent news reports of psychiatric and behavioral issues in young children who have used MiraLAX.
It should be noted that MiraLAX is not FDA approved for use in children under the age of 17. It is also not FDA approved for prolonged use. It is meant to be used only for a duration of no more than 7 days at a time, and by individuals age 17 and over.
Several personal injury lawyers are investigating these claims, but no lawsuits have yet been filed against MiraLAX manufacturer, Bayer.
MiraLAX Usage And Children
Constipation is a problem that plagues many Americans, including children. When children have this problem, parents often turn to over-the-counter laxatives for relief. One popular laxative – MiraLAX – is facing scrutiny over concerns that prolonged usage is causing children to suffer from anxiety, paranoia, mood swings, rage and other behavioral problems.
MiraLAX contains polyethylene glycol 3350, also known as PEG 3350, which can potentially turn into a toxic anti-freeze ingredient. While many medications contain this ingredient, there are concerns that it can be harmful to children, especially since it is not recommended for use in those under age 17.
In 2014, the Food and Drug Administration (FDA) received 167 reports of adverse side effects in children who had used MiraLAX. Of those, 37 had experienced psychiatric or neurological events.
Parent Response
Many parents have shared their experiences with children who have taken MiraLAX. In fact, the Facebook group Parents Against MiraLAX (PEG 3350) was created for parents to voice their concerns. More than 3,500 people are members of this group.
Parents have shared personal stories of how their children became paranoid and full of rage after taking MiraLAX for about 10 days. Many claim that the symptoms never fully subsided. At age 3, one parent notes that her child experienced mood swings and other psychiatric events.
Manufacturer Response
Bayer, the manufacturer of MiraLAX, does not believe the medication causes any safety issues. It has issued this statement:
“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. 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.”
FDA Response
The FDA is aware of these problems occurring in children after taking MiraLAX. Parents have even petitioned the FDA to investigate these events and add a warning label to MiraLAX. The FDA’s current response is that “no action is necessary at this time based on available information.”
The agency’s Adverse Event Reporting System has listed “neuropsychiatric events” as a potential side effect of MiraLAX. However, The FDA has also mentioned that there is a lack of data “to demonstrate a link between PEG 3350 and serious neuropsychiatric issues in children.” While parents may believe that PEG 3350 is harmful, no studies have conclusively linked the MiraLAX ingredient to psychiatric events or other harmful side effects. In fact, more than 100 studies have shown that PEG 3350 is safe for children.
Personal injury attorneys and product liability lawyers regularly review the FDA’s Adverse Event Reporting System. This reporting system provides a searchable database that details dates and specific occurrences of reported negative drug side effects. This information can be especially helpful to plaintiff’s attorneys who need to prove that the manufacturer of a defective or dangerous product had notice that the product was defective.
Additional Studies
The Children’s Hospital of Philadelphia has shown interest in conducting a study of the effects of PEG 3350 on children. In fact, the FDA has awarded a grant to the hospital to do so. The study is still in progress, and a completion date is not yet known.