ClearLax is an over-the-counter treatment for adults with constipation, but it is sometimes given to children for years. The active ingredient (PEG 3350) is very similar to antifreeze that is linked to seizures, tics, behavior problems, and neuropsychiatric events.
What is ClearLax?
ClearLax is a laxative medication that contains Polyethylene Glycol 3350 powder for mixing into a liquid solution that is taken by mouth. It is approved for short-term use in adults, up to 7 days at a time, to relieve occasional constipation. It is sold over-the-counter and is nearly identical to MiraLax.
What is PEG 3350?
PEG 3350 is a chemical made from petroleum that is very similar to Ethylene Glycol (EG), an extremely toxic antifreeze chemical. They are absorbed very differently in the body. However, laxatives containing PEG 3350 usually contain low levels of EG and other toxins left over from the manufacturing process. The FDA allows these impurities in ClearLax because it is safe for occasional use by adults.
How is ClearLax Absorbed?
PEG 3350 is usually regarded as “safe” because very little is absorbed by the stomach and intestines into the bloodstream. While this is true for adults, no one knows how ClearLax is absorbed by children — especially young children with chronic intestinal diseases.
What is the Problem?
Irritated intestinal systems may have less of a natural barrier against toxins. Over time, people with chronic constipation often develop “Leaky Gut Syndrome” (intestinal hyper-permeability). When a dose of ClearLax sits in the intestines for a few days, more of it is absorbed.
Warnings Against Use in Children
Nexgen, the manufacturer of ClearLax, warned against its use in children in response to a Citizen Petition (PDF). The letter was written by Quality Assurance manager Elaine Tanabe in December 2009:
“This product is tested and approved for use by adults only. Labeling clearly states that pediatric safety and effectiveness has not been evaluated for the product and there is no recommended pediatric dose. We do not recommend or endorse this off-label use and we cannot predict the possible problems children may experience using the product.”
Laxatives and Antifreeze Poisoning
The FDA has received thousands of reports of people who experienced side effects of PEG 3350 laxatives. Some of these reports involve “classic symptoms” of antifreeze poisoning, but only low levels of antifreeze chemicals have been found in laxatives.
Laxatives and Metabolic Acidosis
Experts at the FDA have raised concerns about high anion-gap metabolic acidosis, a potentially deadly condition in which the blood becomes too acidic. It is also a complication of antifreeze toxicity.
Seizures & Neuropsychiatric Events
PEG laxatives have also been linked to a wide range of neurological and psychiatric side effects, such as:
- Obsessive-compulsive behaviors
- Repetitive chewing and sucking
- Mood swings