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ClearLax Lawsuit

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ClearLax PEG 3350 powder contains an ingredient similar to antifreeze that is linked to seizures, psychiatric evens, and other side effects. It is only approved for up to 7 days in adults, but some parents give constipated children ClearLax for years.

What is ClearLax?

ClearLax is an over-the-counter laxative very similar to MiraLax. It contains a drug called Polyethylene Glycol 3350 powder (“PEG 3350”). It is mixed with water and taken by mouth once daily for up to 7 days. It is only approved for adults with occasional constipation.

What is PEG 3350?

PEG 3350 powder comes from petroleum and it is similar to the toxic antifreeze chemical Ethylene Glycol (EG), but absorbed very differently. PEG 3350 may also contain low levels of EG due to manufacturing impurities. It is only safe for short-term use in adults.

How Does the Body Absorb ClearLax?

Very little PEG 3350 is absorbed into the bloodstream through the stomach or intestines, which is why many doctors believe it is safe. It may be safe for adults, but no one nows how PEG 3350 is absorbed by a child — especially babies and toddlers with intestinal diseases.

Long-Term Risks of Laxatives

No one knows the long-term risk of ClearLax side effects in children. Young children naturally have less of a barrier against toxins than adults, and chronic intestinal irritation exacerbates this. Constipation can also cause “Leaky Gut Syndrome” (abnormal intestinal permeability) that increases the amount of toxins entering the body.

ClearLax Use in Children

ClearLax is NOT approved for children and no one knows if any dose is safe for a baby or toddler. The manufacturer of ClearLax, Nexgen, responded to concerns about its use in children with the following Warning (PDF) 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.”

How Many People Have Been Injured?

PEG laxatives have been linked to thousands of adverse event reports, including over 150 children. Some victims had symptoms of Ethylene Glycol toxicity (antifreeze poisoning). Extremely low levels of this chemical were detected in some PEG laxatives in 2008 and 2013.

Metabolic Acidosis

PEG laxatives have been linked to reports of high anion-gap metabolic acidosis (too much acid in the blood). This life-threatening condition is also a common symptom of antifreeze poisoning.

Neurological & Psychiatric Events

PEG laxatives have also been linked to neuropsychiatric events. It was listed as a “possible side effect” when the FDA closed a safety investigation in August 2011. The potential behavior issues include:

  • Seizures
  • Tremors
  • Tics
  • Headache
  • Anxiety
  • Lethargy
  • Sedation
  • Aggression
  • Rages
  • Obsessive-compulsive behaviors
  • Repetitive chewing and sucking
  • Paranoia
  • Mood swings
  • Psychosis

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