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Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
Published on: January 31, 2022
Clinical outcomes of pediatric metformin exposures reported to the National Poison Data System®
Sarah Shafer1, Haylea Stuteville2, Shawn M Varney3
1Department of Emergency Medicine, University of Texas, MD Anderson, Houston, TX, USA.
Introduction:
Prior studies suggest metformin exposures in young pediatric patients are low risk, and a triage threshold of 85 mg/kg can be used to reduce unnecessary evaluations. Our objective was to analyze single-substance metformin exposures using the National Poison Data System® to describe the clinical course, outcome, and mg/kg dose of metformin exposures in children under six years old. The secondary objective was to describe outcomes in patients divided into safe (≤85 mg/kg reported dose) and caution (>85 mg/kg reported dose) categories.
Methods:
Using the National Poison Data System®, we analyzed single-substance metformin exposures from 2011-2021 in patients under six years old. We defined two categories of metformin overdose patients: safe (≤85 mg/kg reported dose), who could be managed at home, and caution (>85 mg/kg reported dose), who should be sent to a healthcare facility. Data were summarized with medians with interquartile ranges for continuous variables and percentages for categorical variables.
Results:
There were 8,762 single-substance metformin exposures reported from 2011-2021. Most patients (6,493, 74.1%) were managed in a non-healthcare setting. Critical care admissions accounted for 73 (3.4%) exposures. For the 1,270 (14.5%) patients who had mg/kg data available, 1,081 (85.1%) were in the safe category with ingestions ≤85 mg/kg, while 189 (14.9%) were in the caution category with ingestions >85 mg/kg.
Discussion:
Data were limited due to 59.4% of cases missing follow-up information. However, in patients with follow-up information available, most cases were managed on site (74.1%) and only 2.5% of cases required hospitalization. Caution range patients had ten times more admissions (6%) than safe range patients (0.6%).
Conclusion:
Most exploratory pediatric single-agent metformin exposures were safe and could be managed at home. The ≤85 mg/kg threshold identifies exposures with expected good outcome requiring little to no medical management.
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Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

