Merck’s popular laxative Miralax is only safe to use for 7 days by adults, but it is commonly given to kids for years. The active ingredient Polyethylene Glycol (PEG 3350) is linked to thousands of reports of neurological, psychiatric, and kidney side effects.
Overview
MiraLAX is a laxative that has been on the market since 1999 and is now sold over-the-counter by Merck & Co. It is only FDA-approved for up to 7 days in adults with occasional constipation. Pediatricians commonly recommend Miralax for children who take Miralax for years, but many experts question the safety of Miralax in children.
PEG Laxatives
The active ingredient — Polyethylene Glycol (PEG 3350) — comes from petroleum and it is made of Ethylene Glycol (EG), a toxic antifreeze chemical, but PEG 3350 is not easily absorbed by the body.
Miralax Safety for Babies
Doctors tell parents Miralax is safe for kids because it is all-natural, poorly-absorbed, and hard to overdose. The truth is that Miralax is NOT approved for children and no one knows how they absorb it.
Miralax Neurological & Psychiatric Side Effects
Over 2,500 adverse events involving PEG laxatives were reported to the FDA between 2000 and 2013, including three children who died.
In 2009, experts with the FDA Drug Safety Oversight Board discussed reports of metabolic acidosis (too much acid in the blood), behavior disorders, and neurological or psychiatric events:
“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.”
No FDA Warnings or Miralax Recall
The FDA investigated, but took no action besides listing “neuropsychiatric events” as a potential safety issue with Miralax and other PEG laxatives. The investigation closed in 2009.
FDA Investigation Finds Antifreeze Toxins
It was not the first investigation. In 2008, the FDA tested 8 batches of Miralax. All of them had low levels of Ethylene Glycol (EG) and Diethylene Glycol (DEG) left over from manufacturing PEG 3350.
Miralax Long-Term Side Effects in Children
No one knows how Miralax is absorbed by a child or if it has long-term side effects. One possible explanation for the large number of side effect reports is that children absorb more Miralax than adults, especially very young infants or toddlers with chronic constipation. An irritated intestinal system has less of a barrier against toxins.
Miralax Kidney Damage Lawsuit
In April 2015, a Miralax Lawsuit (PDF) was filed by a man from Pennsylvania who developed severe kidney damage from Miralax. He took Miralax from 2009 until he was hospitalized with oxalate nephropathy in 2013. The lawsuit was filed on April 23, 2015 in the Philadelphia Court of Common Pleas — In RE: Samuel Woniewala vs. Merck & Co, Inc. — Case No. 150402370.
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