The U.S. Food and Drug Administration announced that the safety of an ingredient in an adult laxative usually given to children is under investigation.
Polyethylene glycol 3350 (PEG 3350) is an active ingredient of the laxative, Miralax; and similar generic products that are prescribed to children having constipation. Some children take this drug daily for years. However, the FDA never approved the use of laxatives for long-term daily use either in adults or in children.
According to the FDA, there is little research data about the absorption of PEG 3350 by the intestine of children, particularly in very young children and children who are chronically constipated. The agency’s decision is coming at the heels of receiving a backlog of reports of obsessive-compulsive behavior, tremors, and tics in children taking laxatives with PEG 3350. However, it is not clear if these symptoms are entirely due to the consumption of this laxative.
To ascertain the safety and efficacy of PEG 3350, the FDA-funded Children’s Hospital of Philadelphia study will examine the intestinal absorption of PEG 3350 in very young children and check whether PEG 3350 has a significant link with irregular psychiatric behavior.