Following reports of seizures, epilepsy and other neurological side effects, a growing number of parents are raising serious concerns about problems with MiraLAX, an over-the-counter laxative that is commonly used on a long term basis to treat children suffering from constipation.
About 18,000 individuals have joined a Facebook group established for parents concerned about the potential MiraLAX side effects. According to a recent media reports, many parents are describing a variety of problems they believe may have been caused by use of MiraLAX by their children, which is often recommended by pediatricians for extended periods of time.
In response to the concerns that have emerged in recent years, the FDA and National Institute of Health have helped fund a study designed to look into the risk of MiraLAX problems for children, providing a grant to the Children’s Hospital of Philadelphia (CHOP) to evaluate concerns raised by parents that the laxative may be causing kids to experience anger, aggression, paranoia and other neuropsychiatric problems in pediatric users.
MiraLAX was first approved by FDA in February 1999, as a prescription laxative. In 2006, it was approved for over-the-counter use, but it is not labeled for pediatric use or for use over extended periods of time. The active ingredient is Polyethylene Glycol (PEG) 3350, but some tests have also discovered small amounts of ethylene glycol and diethylene glycol; ingredients found in antifreeze.
To date, the FDA has not placed a label warning on the drug regarding potential MiraLAX risks for children, indicating that there is currently insufficient evidence of a link between PEG 3350 and child psychological side effects. However, the agency did agree to fund further research following parents’ complaints, and acknowledges that it is aware that some doctors prescribe MiraLAX to children for long-term use.
According to a recent report by 13News in Norfolk, Bayer has defended the safety of the drug, indicating that while it is not approved for pediatric use, a number of clinical studies involving the active ingredient PEG 3350 have suggested it is safe for short-term and long-term use by children with chronic constipation.
The Facebook group Parents Against MiraLAX (PEG 3350) was established for parents and family members to discuss the effects the product has on their children, including alternative options and suggestions about ways to talk to doctors.
The FDA has previously confirmed that at least 167 reports of adverse events have been received involving children who experienced MiraLAX neuropsychiatric problems, but this appears to only represent a small fraction of the true number of issues experienced by kids nationwide.