Safety of Adult Laxative Given to Children Questioned by FDA

The Food and Drug Administration (FDA) has requested an examination into the safety of an adult laxative that is routinely administered to constipated children. Miralax (polyethylene glycol (PEG) 3350; Merck) is an osmotic indicated for occasional constipation in adults ≥17 years and is not recommended for children; however, doctors have encouraged the use of this product and similar generics to parents with children suffering from constipation because very little PEG 3350 is absorbed in the intestines. The Children's Hospital of Philadelphia will be leading a study on how PEG 3350 is metabolized in children and whether use of the laxative may be linked to the development of psychiatric problems. 

The FDA inquiry is in response to occasional reports of tremors, tics, and obsessive-compulsive behavior in children given laxatives containing PEG 3350, although it is unknown if the laxatives were the cause of these issues. A brief issued to researchers by the FDA in 2014 noted that small amounts of ethylene glycol (EG) and diethylene glycol (DEG) were detected in eight batches of the laxatives tested but tiny amounts are permitted in finished drug products. This new study will also examine for evidence of EG and DEG in the blood of pediatric patients taking these laxatives chronically and if present, assess potential explanations for their presence.

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