June 26, 2015 — The New York Times reports that a team of researchers in Philadelphia are now studying the link between Miralax, a popular laxative, and serious side effects in children.
Researchers in Philadelphia want to know how much is absorbed by children, especially young children who are routinely given Miralax for chronic constipation.
Miralax is an over-the-counter laxative that is only approved for short-term use in adults — up to seven days — and not in children or teens under 17 years old. Even so, Miralax is commonly used by parents to treat young children with constipation from Crohn’s disease and celiac disease.
There are no studies linking Miralax and serious side effects in children. The label on Miralax does not include warnings about its risks in kids because there are no long-term studies, according to another report by the New York Times.
The problem is that the active ingredient in Miralax, polyethylene glycol (PEG), has been linked to reports of severe side effects. The FDA’s Drug Safety Oversight Board warned in 2009:
“Neuropsychiatric adverse events may include seizures, tremors, tics, headache, anxiety, lethargy, sedation, aggression, rages, obsessive-compulsive behaviors including repetitive chewing and sucking, paranoia and mood swings.”
The board also warned about “metabolic acidosis,” a condition involving too much acid in the bloodstream that can lead to shock or death.
The Times also discovered that the FDA tested eight batches of Miralax in 2008. All of the batches had small amounts of ethylene glycol (EG) and diethylene glycol (DEG), ingredients in antifreeze. These toxins are impurities from the manufacturing process, but the FDA allows small amounts in finished products because it says very little is absorbed in the intestines of an adult during short-term use.
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