The laxative MiraLax (PEG 3350) has been linked to reports of tremors, tics, obsessive-compulsive behaviors and other serious side effects in children, according to the U.S. Food & Drug Administration (FDA).
Free Confidential Lawsuit Evaluation: If your child or other loved one was injured by MiraLax side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What is MiraLax?
MiraLax (polyethylene glycol 3350 or PEG 3350) is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. The drug is used to treat occasional constipation or irregular bowel movements. MiraLax is manufactured by Bayer, and was approved by the U.S. Food & Drug Administration (FDA) in February 1999.
What’s the Problem?
Families across the U.S. are coming forward with claims that their children developed severe neuropsychiatric problems after taking MiraLax. The laxative is commonly prescribed “off-label” (against FDA recommendations) to infants and toddlers, when it’s not intended for use by anyone under the age of 17. Data released by the FDA suggests that MiraLax may contain the same toxic chemicals as those found in car antifreeze.
Household Laxatives Contain Antifreeze: FDA Warning
In June 2014, FDA sent a brief to researchers announcing the results of a study which found the car antifreeze ingredients ethylene glycol (EG) and diethylene glycol (DEG) in 8 batches of MiraLax. The tests were conducted in 2008, but the results were not disclosed. FDA said the toxins were impurities resulting from the manufacturing process.
While trace amounts of EG and DEG are legally permitted in finished drug products, it is unknown whether these chemicals may harm children, especially those given the laxative regularly over a long period of time.
MiraLax Side Effects
- Kidney Damage
- Acute Kidney Injury
- Kidney Failure (End-Stage Renal Disease or “ESRD”)
- Oxalate Nephropathy
- Acidic blood
- Obsessive-Compulsive Behavior
- Neuropsychiatric Events
- Mood Swings
- And more
- Study published in the journal Alimentary Pharmacology and Therapeutics (AP&T) in June 2008 found that orally administered PEG-3350 is minimally absorbed, rapidly excreted and primarily eliminated via feces.
- Study published in Clinics in Colon and Rectal Surgery in February 2009 found that mechanical bowel preparation products (MBP) like MiraLax offer no benefit as a preoperative measure and question their place in current surgical practices.
- Study published in PLOS ONE in February 2012 found that standard bowel cleansing preparations alter the mucosal-adherent microbiota. The findings underscore the importance of considering the confounding effects of bowel preparation when designing experiments exploring the gut microbiota, according to the researchers.
- 2014 Study published in the Journal of Pediatric Pharmacology and Therapeutics found that while propylene glycol is generally considered safe, toxicity can occur when used in high doses or for prolonged periods. Reported adverse effects from propylene glycol toxicity include central nervous system (CNS) toxicity, hyperosmolarity, hemolysis, cardiac arrhythmia, seizures, agitation, and lactic acidosis. Patients at risk for toxicity include infants, those with renal or hepatic insufficiency, epilepsy, and burn patients receiving extensive dermal applications of PG containing products.
- Study published in the European Journal of Gastroenterology & Hepatology in May 2016 found that high-volume polyethylene glycol bowel cleansing preparation has a long-lasting effect on the gut microbiota composition and homeostasis, with a decrease in the Lactobacillaceae abundance, a population of protective bacteria.
MiraLax Kidney Injury Lawsuit
A Philadelphia man has filed a lawsuit against Bayer alleging that side effects of MiraLax caused him to develop an acute kidney injury. Plaintiff Samuel Woniewala claims he used MiraLax regularly, which led to a rare condition known as oxalate nephropathy, in which massive amounts of calcium oxalate build up in the body causing acute kidney injury. Woniewala claims his prognosis is dismal, and that he requires ongoing dialysis and may even need a kidney transplant in order to live.
“At all times relevant and material hereto, the defendants manufactured, marketed, sold and advertised MiraLax, without sufficient investigating the effect of MiraLax on kidney function, and/or without acknowledging this deadly side effect,” the complaint states.
What Else Can I Give My Child for Constipation?
Instead of taking MiraLax to relieve the symptoms of your child’s constipation, try natural, fiber-containing foods, lots of water and regular exercise. Mineral oil, lactulose, and fiber supplements (solutions, gummies, bars, etc.) can also be used to control mild constipation. Talk to your doctor to ensure the correct plan for your child. To learn more about MiraLax, please visit out MiraLax FAQ page.
Do I Have a MiraLax Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in MiraLax lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if your child suffered an injury after taking a laxative, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.