Dosing Strategies for High-Alert Medications in Obese Pediatric Patients: A Systematic Review
Abstract
Background/Objective: Childhood obesity induces physiological changes that alter drug distribution and clearance; however, these patients are often excluded from clinical trials, creating a critical safety gap for high-alert medications (HAM). The Objective was to evaluate HAM dosing strategies and pharmacokinetic (PK) alterations in overweight and obese pediatric patients. Methods: A systematic review was conducted and registered in PROSPERO (CRD42023452126). A search of MEDLINE, EMBASE, Web of Science, and Cochrane CENTRAL (1990-March 2026) identified studies reporting dosing strategies or PK of HAM in obese or overweight pediatric patients. Studies were included if they reported dosing recommendations or PK parameters. Eligible designs comprised prospective and retrospective, randomized and non-randomized, observational (cohort, case-control, and cross-sectional), case series, case reports, and narrative and systematic reviews. Study selection, data extraction, and quality assessment were conducted independently by two reviewers. Methodological quality was assessed using validated tools, and results were synthesized qualitatively. Results: Of 5801 records, 91 studies were included, providing evidence for only 27% of the evaluated HAM. Total body weight (TBW) appeared to be appropriate for insulin and vancomycin, although close monitoring was required. TBW-based dosing was associated with approximately 20% overexposure for enoxaparin, supporting the use of fat-free mass…
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