FDA Investigating Laxative Ingredient's Safety

From the WebMD Archives

Jan. 6, 2015 -- The safety of an ingredient in an adult laxative commonly given to children is being investigated, the U.S. Food and Drug Administration says.

Polyethylene glycol 3350 (PEG 3350) is the active ingredient in Miralax and similar generic products that are given to constipated children, sometimes daily for years. However, the FDA has never approved long-term daily use of the laxatives in adults or children, The New York Times reported.

While it's widely believed that very little PEG 3350 is absorbed into the intestines, there is little data on its absorption in children, especially the very young and chronically constipated, according to the FDA.

Also, the agency has received some reports of tremors, tics and obsessive-compulsive behavior in youngsters taking laxatives with PEG 3350. It's not clear whether these problems are caused by the laxatives, The Times reported.

The FDA-funded Children's Hospital of Philadelphia study will examine whether PEG 3350 might be absorbed by very young children and whether the use of laxatives with PEG 3350 is associated with psychiatric problems.

"It's a medicine that helps a fair number of children," study co-investigator Dr. Ritu Verma, section chief of clinical gastroenterology at the hospital, told The Times. "We want to be sure it's not harming them."

In 2012, an advocacy group called the Empire State Consumer Project petitioned the FDA to reopen an investigation into the safety of PEG 3350.

"Finally, they will measure changes in behavior," group co-director Carol Chittenden told The Times. "We absolutely want that."

In a brief to researchers last year, the FDA also said its scientists discovered trace amounts of two antifreeze ingredients in eight batchers of Miralax tested six years ago. The toxins were impurities caused by the manufacturing process, according to the FDA.

Miralax is intended to be used once daily by adults, according to a statement released by drug maker Bayer, which also said it is "committed to ensuring the product meets all specifications for quality."

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