Drs. Robert Heuckeroth, Ritu Verma to lead FDA investigation on safety of adult laxative for children

Robert O. Heuckeroth, MD, PhD, and Ritu Verma, MBChB, will lead a study assessing the safety of a laxative for adults that is often given to constipated children, according to a New York Times report.

Dr. Heuckeroth is a pediatric gastroenterologist with the University of Pennsylvania's Perelman School of Medicine in Philadelphia. Dr. Verma is director of the Center for Celiac Disease and the Lustgarten Endowed Chair for Clinical Care of GI Motility Disorders at The Children's Hospital of Philadelphia.

Drs. Heuckeroth, Verma and their team have been asked by the U.S. Food and Drug Administration to look closely at the active ingredient in Miralax and similar generic products, called polyethylene glycol 3350, or PEG 3350.

The FDA stated that six years ago its scientists had discovered trace amounts of two potential toxins in batches of Miralax. There is very little PEG 3350 absorbed by the intestine in adults and hence, the agency continued to recommend it. However, there little evidence of the absorption in children.

Additionally, over the years the FDA has received some reports of tremors, tics and obsessive-compulsive behavior in children who used the laxatives containing PEG 3350, but it is not known if these laxatives are the cause.

The FDA issued nearly $325,000 to The Children’s Hospital of Philadelphia to study these issues, according to the report.  

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