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PureLax Lawsuit

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CVS stores sell PureLax, a laxative that contains PEG 3350. This ingredient is closely related to antifreeze and it has been linked to a possible risk of neuropsychiatric side effects, seizures, and metabolic acidosis.

What is PureLax?

PureLax is the CVS drugstore-brand version of MiraLax, an over-the-counter laxative. It contains Polyethylene Glycol 3350 powder (“PEG 3350”) that is mixed with water and taken by mouth. It softens stools and relieves constipation by pulling water from the body into the intestines.

How to Use PureLax

PureLax is only safe for short-term use (7 days maximum), one dose per day (up to 17g powder), and only for adults over 17 years old who suffer from occasional constipation — not long-term constipation. PureLax powder is mixed with water and taken orally.

What is PEG 3350 Powder?

The only ingredient in PureLax is Polyethylene Glycol 3350 powder (“PEG 3350”). This is a petroleum-based compound that is very similar to Ethylene Glycol (EG), a common ingredient in antifreeze. While EG is extremely poisonous, PEG 3350 is relatively safe because it is poorly absorbed by the intestines into the bloodstream. PEG 3350 may contain low levels of EG left over from manufacturing. This is why it is only safe for healthy adults, but only for 7 days.

How Do Children Absorb PEG 3350?

No one knows how children absorb PEG 3350 from PureLax — especially babies or toddlers who are constipated or suffering from a serious underlying intestinal disease. The child’s irritated intestinal system may have less of a barrier against toxins. Over time, constipation also increases the permeability of the intestines.

Is PureLax Safe for Children?

PureLax is NOT approved for children. It had not been studied for safety in children and there is no recommended dose for babies. Even so, many pediatricians recommend PureLax, falsely assuming it is safe for children because it is poorly-absorbed by adults.

PureLax and Metabolic Acidosis

Drug safety experts at the FDA warned about a possible risk of metabolic acidosis after receiving reports associated with PEG laxatives. This potentially deadly condition occurs when the blood becomes too acidic. PEG laxatives were linked to “high anion-gap metabolic acidosis,” the same type linked to antifreeze poisoning.

PureLax and Neuropsychiatric Events

Neuropsychiatric events (neurological, behavioral, and psychiatric disorders) were listed as a “possible side effect” of PEG laxatives when the FDA closed its safety investigation in August 2011. Warnings were based on thousands of voluntary reports of injuries, such as:

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

Other Serious Side Effects of PureLax

Anaphylaxis: Do not take PureLax if you have ever had an allergic reaction to PEG 3350 laxatives.

Kidney Problems: Do not take PureLax if you have pre-existing kidney disease, unless under a doctor’s advice and supervision. PureLax could exacerbate kidney problems and lead to complications, such as:

  • Kidney damage
  • Acute kidney injury
  • Kidney failure
  • End-stage renal disease (ESRD)
  • Oxalate nephropathy
  • Dialysis
  • Kidney transplant

Serious Gastrointestinal Problems: Before you take PureLax, talk to a doctor if you have a sudden change in bowel habits lasting 2 weeks or more, nausea, vomiting, abdominal pain, or Irritable Bowel Syndrome (IBS). PureLax causes stools that are loose, watery, and more frequent. You should stop taking PureLax and contact a doctor if you develop:

  • Rectal bleeding, worsening nausea, bloating, cramping, or abdominal pain.
  • Diarrhea
  • Constipation lasting more than 7 days. PureLax is only approved for up to one week.

 

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