GaviLax is an adult laxative that is given to children for years. It contains PEG 3350, a chemical like antifreeze (Ethylene Glycol). No one knows the risks in kids. There are reports of neurological and psychiatric side effects, seizures, and behavior disorders.
What is GaviLax?
GaviLAX® (Polyethylene Glycol 3350) powder is an osmotic laxative. It relieves constipation by pulling water from the body into the bowel to soften stools and increase the number of bowel movements. It is made by Gavis Pharmaceuticals.
How Should GaviLax Be Used?
GaviLAX is a powder that is mixed with water and taken by mouth. It is only approved for short-term use (up to 7 days) with a once-daily dose up to 17g. It is only safe for use in adults over 17 years old who suffer occasional constipation. Do not use GaviLax if you have kidney disease, except under the advice and supervision of a doctor.
Is GaviLax Safe for Children?
GaviLax is NOT approved for children or long-term use in anyone. Ask a doctor before giving GaviLax to children under 16 years old. Doctors may recommend GaviLax for children with chronic constipation, but no one knows the short-term risks or long-term health effects because there are no adequate safety studies.
What is PEG 3350?
The laxative in GaviLax is Polyethylene Glycol 3350 (“PEG 3350”). This petroleum-derived chemical is made of Ethylene Glycol, also known as antifreeze, but they are absorbed very differently.
What Your Doctor Doesn’t Tell You
Doctors might tell you PEG 3350 is safe for a child because it is “all-natural,” minimally-absorbed by the body, and hard to overdose. It is true that PEG 3350 is natural — it comes from petroleum, like plastic.
No one knows the “safe” dose of GaviLax for a baby or toddler, so parents usually start with a teaspoon and freely adjust as needed. This can lead to dangerous overdoses of PEG 3350 in children.
GaviLax is minimally absorbed by an adult, but children might be absorbing more than adults — especially very young children who are suffering from chronic constipation or underlying intestinal diseases.
How Do Children Absorb GaviLax?
No one knows. Children with irritated intestinal systems might have less of a barrier against GaviLax. This would help explain the large number of adverse events in kids. Constipation also stretches out the intestines, making them even more permeable, which is why “Leaky Gut Syndrome” is so common in people with digestive diseases.
Neuropsychiatric Side Effects of PEG 3350
- Obsessive-compulsive behaviors
- Repetitive chewing and sucking
- Mood swings
FDA Safety Investigation into PEG Laxatives
The FDA closed the PEG laxative safety investigation in 2011. Neuropsychiatric events are listed as a “possible side effect” of laxatives like GaviLax. In 2015, the agency awarded a $325,000 grant to a hospital in Philadelphia study how PEG is absorbed by the body of a young child with chronic intestinal problems.
What is the Problem?
Thousands of people have reported metabolic acidosis, neurological, and psychiatric side effects of PEG 3350 laxatives like GaviLax.
In June 2009, the FDA Drug Safety Oversight Board reviewed the reports and warned about metabolic acidosis, a condition where the blood is too acidic. It is also a symptom of antifreeze poisoning. The board also warned about neuropsychiatric 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.”
Antifreeze Chemicals in PEG Laxatives
The FDA said it tested 8 batches of Miralax (PEG 3350) in 2008 after reports of people who had symptoms consistent with antifreeze poisoning. All of the batches tested positive for low levels of the toxic antifreeze chemicals Ethylene Gylcol (EG) and Diethylene Glycol (DEG) left over from manufacturing PEG 3350.
In 2013, the FDA completed another round of tests on 5 different over-the-counter laxatives containing PEG 3350. None had detectable levels of EG or DEG. “The amounts were so low,” the FDA told the New York Times, and “complied with internationally recognized safety standards.”