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Alleged MiraLAX Pediatric Neuropsychiatric Issues Being Investigated

Santa Clara, CA: Reports of mental health issues in children who were exposed to the laxative MiraLAX are being investigated by the Children’s Hospital of Philadelphia (CHOP) in a study funded by US Food and Drug Administration (FDA) and the National Institutes of Health (NIH).

The study received $325,000 in funding from the FDA and NIH in 2014 as a result of petitions from groups such as Parents Against MiraLAX (PEG 3350) Facebook group.

Notably, the FDA has received at least 167 reports of adverse events regarding children who experienced neuropsychiatric problems after being exposed to MiraLAX.

The CHOP study is investigating claims that MiraLAX may be associated with neuropsychiatric side effects in pediatric uses which include but are not limited to anger, aggression and paranoia.

Approved for prescription use in February 1999 by the FDA, MiraLAX then received over the counter approval in 2006. It is not, however, labeled for pediatric use or for use over prolonged periods of time. The active ingredient in MiraLAX is Polyethylene Glycol (PEG) 3350. Some tests have also revealed small amounts of ethylene glycol and diethylene glycol, which are ingredients used in antifreeze.

The maker of MiraLAX, Bayer, has stated that previous studies did not indicate any psychiatric adverse events associated with the laxative, however they emphasize that it is not approved or use in children. Bayer also states that the amounts of ethylene glycol and diethylene glycol detected were small enough to be well within accepted safety margins.

So far, the FDA has not placed a label warning on MiraLAX. However, the agency has acknowledged it is aware some doctors prescribe MiraLAX to children for long-term use.

Currently, no information has been released about the CHOP study, which is underway. Results from the study will be submitted to the FDA once it is complete.



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Last updated on Mar-17-17


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