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GaviLax Lawsuit


GaviLax is an adult laxative that is commonly given to children for years. It contains a chemical similar to antifreeze (Polyethylene Glycol 3350) that is linked to reports of seizures, tremors, metabolic acidosis, neurological, psychiatric, and behavioral side effects.

What is GaviLax?

GaviLAX® is a laxative for short-term use in adults. The active ingredient is Polyethylene Glycol 3350 powder (“PEG 3350”), an osmotic laxative that softens stools to relieve constipation.

Who Can Use GaviLax?

GaviLax is sold over-the-counter, but that does not mean it is always safe. It is only approved for adults over 17 years old who suffer from occasional constipation (not long-term digestive disease). The maximum dose is 17g once-a-day for up to 7 days at a time.

Who Should Not Use GaviLax?

GaviLax should not be used by people with kidney disease, except under a doctor’s advice and supervision. GaviLax is NOT approved for children, but the label says “Ask a Doctor” about use in kids under 16.

What is PEG 3350?

PEG 3350 powder is Polyethylene Glycol, a petroleum-derived compound. It is made from Ethylene Glycol, a toxic antifreeze chemical, but they are absorbed very differently in the body.

What Doctors Tell You… And Don’t Tell You

There is a long-standing belief in the medical community that PEG 3350 laxatives are “safe” because they are minimally-absorbed by the stomach and intestines into the bloodstream. This is true — for adults — but no one knows how PEG laxatives are absorbed by children. In 2015, the FDA awarded $325,000 to the Children’s Hospital of Philadelphia to study the absorption of PEG in very young children with chronic constipation.

PEG Laxative Safety in Children

Young children might be absorbing more PEG than adults, which would help explain the large number of adverse events, but no one knows. Many people with chronic constipation develop “Leaky Gut Syndrome” (intestinal hyper-permeability), in which the intestines absorb more toxins because the body’s natural barrier breaks down.

Antifreeze Toxins in Laxatives

In 2008, the FDA tested 8 batches of PEG laxatives after receiving reports of people who had “classic symptoms” of antifreeze poisoning. All of the laxatives tested positive for very small amounts of the toxic antifreeze chemicals ethylene glycol and diethylene glycol left over from the manufacturing process for PEG 3350.

Possible Risk of Neuropsychiatric Events

In the meantime, the FDA lists neuropsychiatric events as a “possible side effect” of PEG 3350 laxatives like GaviLax and Miralax. In 2011, the FDA’s PEG safety investigation ended with no recalls or warnings against using it in children. Even so, experts identified the following risks:

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

High Anion-Gap Metabolic Acidosis

There have been reports of people who developed too much acid in the blood — metabolic acidosis — after using PEG laxatives. People who are poisoned by antifreeze (ethylene glycol toxicity) commonly develop high anion-gap metabolic acidosis. This condition can be mild and ongoing, or it can be life-threatening.

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