Probable neuropsychiatric toxicity of polyethylene glycol: roles of media, internet and the caregivers

Hussain, Sunny Z.; Belkind‐Gerson, Jaime; Chogle, Ashish; Bhuiyan, Mohammad Alfrad Nobel; Hicks, Timothy; Misra, Sudipta

doi:10.1002/ygh2.336

Cited by 10 publications

(6 citation statements)

References 14 publications

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“…This overlap has made it difficult to interpret whether neuropsychiatric symptoms in children taking PEG3350 are secondary to laxative use or naturally co‐occur with the underlying constipation. Although multiple studies have reported on the safety of PEG3350 (4–6,8,11), parents are still reluctant to use PEG3350 (38). Although we cannot rule out that laxatives affect behavior in children with chronic constipation, our study found no evidence that PEG3350 (or magnesium citrate) significantly affects anxiety‐like behavior in mice tested on standard tasks.…”

Section: Discussionmentioning

confidence: 99%

Polyethylene Glycol 3350 Changes Stool Consistency and the Microbiome but not Behavior of CD1 Mice

Salman

Williams

Marte-Ortiz

et al. 2021

Journal of Pediatric Gastroenterology &Amp; Nutrition

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Objectives: Polyethylene Glycol 3350 (PEG3350) is a laxative commonly used to treat constipation in children. The Food and Drug Administration has received reports of increased anxiety, aggression, and obsessive-compulsive behaviors in children administered PEG3350. Thus, we assessed whether daily administration of PEG3350 leads to anxiety-like behavior in mice. Methods: Outbred CD-1 IGS mice were administered either a high or a low dose of PEG3350 via daily oral gavage for 2 weeks. As a laxative comparison and control, additional mice were given a high or low dose of magnesium citrate or vehicle (water). Weight and stool consistency were assessed after each gavage to determine laxative effectiveness. Anxiety-like behaviors were assessed using light/dark, open field, and elevated plus maze (EPM) tests at baseline, after 2 weeks of daily gavage, and after a 2 week washout in experiment 1, and after 2 weeks of daily gavage in experiment 2. Stool samples were collected for microbiome analysis in experiment 2 at baseline, after 2 weeks of daily gavage, and after 2 weeks washout. Results: PEG3350 and magnesium citrate significantly changed stool consistency, as well as microbiome alpha and beta diversity. Anxietylike behaviors were not, however, different in mice administered low or high doses of PEG3350 or magnesium citrate. Conclusions: Although changes in stool consistency and the gut microbiome occurred, administration of PEG3350 did not alter anxiety-like behaviors.

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Section: Discussionmentioning

confidence: 99%

Polyethylene Glycol 3350 Changes Stool Consistency and the Microbiome but not Behavior of CD1 Mice

Salman

Williams

Marte-Ortiz

et al. 2021

Journal of Pediatric Gastroenterology &Amp; Nutrition

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“…Although laxatives are commonly used for the management of chronic childhood constipation, there is a paucity of data addressing their efficacy, safety, and tolerability ( 7 ). The commonly used laxative polyethylene glycol has come under scrutiny, with gastrointestinal (GI) and neuropsychiatric adverse events (AEs) reported ( 8 , 9 ). Despite the chronic nature of the disease, no trials have examined the long-term benefits of drug therapy in PFC ( 7 ).…”

mentioning

confidence: 99%

Safety of Lubiprostone in Pediatric Patients With Functional Constipation

Hussain

Labrum

Mareya

et al. 2021

J. pediatr. gastroenterol. nutr.

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Objectives: Pediatric functional constipation (PFC) affects up to 30% of children. Current treatments often do not sustain symptomatic relief. Lubiprostone is a locally acting chloride channel activator that promotes fluid secretion into the small bowel without affecting serum electrolyte concentrations. We assessed the safety/tolerability of oral lubiprostone as treatment for PFC in a 24-week study. Methods: This phase 3 open-label safety trial conducted from April-November 2016 at 13 US sites included patients (ages 6–17 years) diagnosed with PFC (Rome III criteria). Patients <50 and ≥50 kg received lubiprostone 12 or 24 mcg twice daily, respectively, for 24 weeks. Safety endpoints included incidence of treatment-emergent adverse events (TEAEs) and changes from baseline in clinical laboratory parameters and vital signs. Results: Overall, 87 patients receiving lubiprostone, 64.3% (36/56) in the 12-mcg group and 54.8% (17/31) in the 24-mcg group, completed the study. Of 12 TEAEs leading to discontinuation, only upper abdominal pain occurred in >1 patient. TEAEs were mostly mild in intensity, with gastrointestinal disorders (diarrhea, vomiting) most frequently reported. No safety concerns were found in vital signs, abbreviated physical examinations, and laboratory tests. Subgroup analyses assessed an impact of age, sex, and race categories on TEAEs and treatment-related adverse events. Mean investigators’ assessments of treatment effectiveness (scale of 0–4) for lubiprostone 12- and 24-mcg groups, respectively, were 2.8 and 2.9 at week 12, and 2.7 and 2.2 at week 24. Conclusions: Lubiprostone was well tolerated in the pediatric population. The incidence of TEAEs was comparable to that observed in previous clinical trials and in adults.

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“…Ключові слова: функціональний запор, діти, «Інулін-Нео». Батьки дітей із запорами бояться призначення препаратів упродовж тривалого періоду через залежність від проносних засобів чи їхні можливі побічні ефекти [2,10,18]. Таким чином, існує потреба у вивченні інших варіантів лікування у дітей із ФЗ.…”

Section: оцінка ефективності застосування інуліну при функціональному...unclassified

Evaluation of the efficacy of inulin use in children with functional constipation

Nyankovska¹,

Nyankovskyy²,

Yatsula³

et al. 2022

СГ

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Functional constipation (FC) is a common pediatric problem accounting for 3 % visits to a general pediatrician and up to 25 % visits to a pediatric gastroenterologist. Presence of FC significantly impacts a child’s health‑related quality of life and the healthcare cost burden. The North American Society of Pediatric Gastroenterology, Hepatology, and Nutrition Guideline (NASPGHAN) recommends supportive treatment with laxatives, training, recommendations on fiber and fluid intake, and physical activity in constipation in children. Modern pharmacological treatments may be ineffective in some patients — not optimal dosage, poor compliance or use of drugs with mechanisms of action that do not affect the main pathophysiological moments. Many patients with constipation report dissatisfaction with traditional treatments due to perceived lack of efficacy. Objective — to study the effectiveness of the prebiotic Inulin Neo for pediatric patients with functional constipation aged 3 to 18 years. Materials and methods. Observation involved 48 children aged 3 to 18 years with a diagnosis of functional constipation. Patients were divided into two groups. The main group consisted of 29 children who received the prebiotic Inulin Neo. The control group included 19 children who did not receive prebiotic. Results. After 30 days of treatment, children of the main group vs control group demonstrated significantly better positive dynamics of the following indices: relief of abdominal pain and pain during defecation, decrease in colic and bloating, normalized frequency of defecation and consistency of stools, increased bifidoflora amount and normalized coprological indicators. The results suggest effectiveness of Inulin Neo and feasibility of its inclusion into the treatment of functional constipation in children. Conclusions. Symptoms of functional constipation significantly decreased or disappeared in children who received Inulin Neo, most of the indices of microbiocenosis and coprological investigations considerably improved, whereas pediatric patients of the control group demonstrated only the trend to their improvement. No intolerability signs or adverse events during Inulin Neo administration have been revealed.

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Probable neuropsychiatric toxicity of polyethylene glycol: roles of media, internet and the caregivers

Cited by 10 publications

References 14 publications

Polyethylene Glycol 3350 Changes Stool Consistency and the Microbiome but not Behavior of CD1 Mice

Polyethylene Glycol 3350 Changes Stool Consistency and the Microbiome but not Behavior of CD1 Mice

Safety of Lubiprostone in Pediatric Patients With Functional Constipation

Evaluation of the efficacy of inulin use in children with functional constipation

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