A study has been launched to investigate recent reports that suggest the laxative MiraLAX may be causing mental problems among children.
The Children’s Hospital of Philadelphia (CHOP) is conducting a study to evaluate parents’ claims that MiraLAX side effects can cause anger, aggression, paranoia and other neuropsychiatric problems in pediatric users.
Following a petition by parents, such as the Parents Against MiraLAX (PEG 3350) Facebook group, the FDA and National Institute of Health gave a $325,000 grant to CHOP in 2014 to conduct the study, which is now reportedly underway.
The study also came after the FDA received at least 167 reports of adverse events regarding children who experienced MiraLAX neuropsychiatric problems.
MiraLAX is a laxative approved by FDA for prescription use in February 1999, and later was approved for over-the-counter use in 2006. However, it is not labeled for pediatric use or for use over extended periods of time. It’s active ingredient is Polyethylene Glycol (PEG) 3350. 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, indicating that there is currently insufficient evidence of a link between PEG 3350 and child psychological problems. 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.
Bayer has defended MiraLAX safety, maintaining that previous studies have shown no psychiatric side effects from the drug, and indicating that the amounts of ethylene glycol and diethylene glycol detected were small enough to be well within accepted safety margins. The company also emphasizes that it warns that the drug is not approved for use by children.
There have been no details released about the CHOP study currently underway. The hospital has said it will submit its findings to the FDA when they are completed.