Miralax Safety in Children Questioned

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June 26, 2015 — Researchers in Philadelphia have launched a study to investigate the safety of giving the laxative Miralax to children with chronic constipation.

Miralax is an over-the-counter drug for treating constipation in adults. It is only approved for short-term use up to 7 days and it is not recommended for children under 17 years old. Even so, many parents routinely give Miralax to treat young children with chronic constipation.

No studies have shown that Miralax has severe side effects. The warning label does not specifically warn about risks in children because no long-term studies have been conducted in children, according to the New York Times.

The problem is that Miralax contains a laxative drug called polyethylene glycol (PEG). In 2009, the FDA’s Drug Safety Oversight Board warned that neuropsychiatric side effects of PEG may include “seizures, tremors, tics, headache, anxiety, lethargy, sedation, aggression, rages, obsessive-compulsive behaviors including repetitive chewing and sucking, paranoia and mood swings.”

PEG has also been linked to reports of “metabolic acidosis,” or too much acid in the blood, which can lead to shock or death in severe cases.

The New York Times uncovered even more disturbing news:

“The FDA said that it had tested eight batches of Miralax and found tiny amounts of ethylene glycol (EG) and diethylene glycol (DEG), ingredients in antifreeze, in all of them. The agency said the toxins were impurities resulting from the manufacturing process.”

The FDA allows small amounts of these toxins in finished products. The agency says very little is absorbed in the intestines when laxatives are only used for seven days by an adult. However there is scant data on how much is absorbed by children, especially those who are very young and given laxatives for chronic conditions like Crohn’s disease or celiac disease.

 

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