FDA Questions Safety of Laxatives as Childhood Remedy
MiraLax contains the active ingredient polyethylene glycol 3350, or PEG 3350, which has been linked to reports of tremors, tics and obsessive-compulsive behaviors in children. In September 2014, the U.S. Food & Drug Administration (FDA) awarded nearly $325,000 to The Children’s Hospital of Philadelphia (CHOP) to study how PEG 3350 is absorbed in children, and whether use of the laxatives may increase the risk of psychiatric problems. The study was applauded by the non-profit Empire State Consumer Project (ESCP), which petitioned the FDA in 2012 to reopen an investigation into the safety of PEG 3350.
How Does MiraLax Work?
MiraLax works by increasing the amount of water in the intestinal tract to stimulate bowel movements. The drug is used to treat occasional constipation or irregular bowel movements. Unfortunately, MiraLax has been shown to contain the highly toxic chemicals ethylene glycol (EG) and diethylene glycol (DEG),ingredients found in automotive antifreeze and brake fluid.
MiraLax Side Effects
Our lawyers are filing lawsuits on behalf of children and teens (16 years and younger) who developed any of the following side effects after taking MiraLax:
- Medically diagnosed neuropsychiatric disorders or injuries
- Acute Kidney Injury
- Obsessive-Compulsive Disorder (OCD)
- Mood disorders
- 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.
Ethylene Glycol Poisoning
Ethylene glycol is a colorless, odorless, sweet-tasting chemical that is toxic if swallowed. The primary symptoms of ethylene glycol poisoning include nausea, vomiting, convulsions, stupor (decreased level of alertness), and coma.
An overdose of ethylene glycol can cause severe damage the brain, lungs, liver, and kidneys. The poisoning causes disturbances in the body’s chemistry, including metabolic acidosis. The side effects may be severe enough to cause shock, organ failure, and even death.
Can I Participate in a Class Action?
Although Schmidt & Clark, LLP, is a nationally recognized class action law firm, we have decided against the filing of a MiraLaw class action lawsuit, and instead are only accepting potential individual claims on behalf of people with the most serious injuries. In this type of complex pharmaceutical litigation, class action lawsuits often result in “lowball settlements” and higher attorney fees for class members. Our lawyers understand that injured parties are suffering emotionally and economically, and we plan to maximize each client’s recovery by filing individual MiraLax lawsuits on their behalf.
Need More Info?
If you’d like to learn more about MiraLax, please visit our MiraLax FAQ page.
Do I Have a MiraLax Lawsuit?
The Class Action 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 you were injured by the side effects of a laxative, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.