Closer look at the ingredient PEG 3350.
By The American Bazaar Staff
WASHINGTON, DC: Dr. Ritu Verma, the section chief of clinical gastroenterology at The Children’s Hospital of Philadelphia, is among a team of scientists who have been asked by the Food and Drug Administration (FDA) to study the safety of an adult laxative routinely given to constipated children, sometimes daily for years, reported The New York Times.
FDA wants Verma, a study co-investigator, and other scientists to look more closely at the active ingredient in Miralax and similar generic products, called polyethylene glycol 3350, or PEG 3350. While outlining the scope of the research, the agency also disclosed that its scientists had discovered trace amounts of two potential toxins in batches of Miralax tested six years ago, reported Catherine Saint Louis for The New York Times.
Doctors have long recommended these laxatives for their convenience and on the grounds that very little PEG 3350 is absorbed in the intestines. But the F.D.A. says there is little data on its absorption in children, especially the very young and chronically constipated. The agency never approved long-term daily use of the laxatives, even in adults, points out the Times report.
Moreover, for years the F.D.A. has received occasional reports of tremors, tics and obsessive-compulsive behavior in children given laxatives containing PEG 3350. It is not known whether the laxatives are the cause, reported the Times.
In September, the agency awarded nearly $325,000 to The Children’s Hospital of Philadelphia to study whether PEG 3350 might be absorbed by the very young and whether use of the laxatives is linked to development of psychiatric problems.
“It’s a medicine that helps a fair number of children,” Verma is quoted as saying in the report by Louis. “We want to be sure it’s not harming them.”
In a statement, Bayer, which acquired Miralax last year, reiterated that the product was intended to be used once daily by adults and said, “We are committed to ensuring the product meets all specifications for quality.”
Psychiatric illnesses like those reported in children taking the laxatives have also been observed in cases in which a child took substantial amounts of ethylene glycol. Some children taking Miralax chronically also have developed acidic blood, according to F.D.A. records, which can be a consequence of ingesting EG.
The new study in Philadelphia will address how PEG 3350 is metabolized by children and whether they have evidence of toxins in their blood, the Times report said.
The researchers will enroll children who have already been taking a PEG 3350 laxative for at least a month, the Times report said. They will be divided into three groups: children who are healthy except for their constipation; those with bowel ailments, like Crohn’s disease or celiac disease; and those who have underlying issues with their nervous system, like cerebral palsy patients. The study also will include a comparison group not taking PEG 3350.
Read the full report in The New York Times here:
http://www.nytimes.com/2015/01/06/science/scrutiny-for-a-childhood-remedy.html?_r=0
(This story was revised on 1/8/2015)