![]() 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. ![]() Reported adverse effects from propylene glycol toxicity include central nervous system (CNS) toxicity, hyperosmolarity, hemolysis, cardiac arrhythmia, seizures, agitation, and lactic acidosis. 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.The findings underscore the importance of considering the confounding effects of bowel preparation when designing experiments exploring the gut microbiota, according to the researchers. Study published in PLOS ONE in February 2012 found that standard bowel cleansing preparations alter the mucosal-adherent microbiota.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 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.The petition was granted in 2014, with the goal of the research being to determine whether PEG 3350 breaks down into the toxic chemicals ethylene glycol and diethylene glycol in the body, increasing the risk for adverse psychiatric events in children. In 2012, the Rochester, New York-based Empire State Consumer Project (ESCP) filed a petition with the FDA to reopen its investigation into the safety of PEG 3350. Kidney Failure (End-Stage Renal Disease or “ESRD”).The tests were performed because many of the adverse events reported were consistent with ethylene glycol poisoning. These were impurities from the manufacturing process, according to the agency. In 2008, FDA tested 8 batches of Miralax and found small amounts of the car antifreeze ingredients ethylene glycol (EG) and diethylene glycol (DEG) in all batches. FDA has received reports of obsessive-compulsive behavior, tics, tremors and other neuropsychiatric side effects in children taking PEG 3350 laxatives. The laxative is given routinely (and sometimes daily) to constipated children, yet it has never been approved for long-term daily use, neither in adults nor children. FDA Questions Laxative Use as Childhood RemedyĪt the request of the FDA, scientists at Children’s Hospital of Philadelphia (CHOP) are studying how children metabolize PEG 3350 and whether its use could be tied to psychiatric problems in children, according to the New York Times. Food & Drug Administration (FDA) in February 1999. MiraLax is manufactured by Bayer, and was approved by the U.S. The drug works by bringing water into the bowels, which helps keep the digestive system regular. MiraLax (generic: polyethylene glycol 3350 or “PEG 3350”) is an over-the-counter treatment for occasional constipation. When used “off-label” in children, the laxative powder MiraLax has been linked to severe neuropsychiatric problems including tremors, tics, obsessive-compulsive behaviors, and more. ![]()
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