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Neonatal perforation of intestine caused by drug — Clinical Guidelines

Overview

Neonatal perforation of the intestine caused by drugs is a severe adverse drug reaction (ADR) that can lead to significant morbidity and mortality in neonates, often associated with the use of medications prescribed off-label. 3 4

Diagnosis

Clinical Presentation: Abdominal distension, signs of peritonitis, and radiographic evidence of bowel perforation.

Recommended Tests: Abdominal imaging (ultrasound, CT), laboratory tests (elevated white blood cell count, electrolyte imbalances).

Causality Assessment: Use of tools like Naranjo or Du algorithms; however, reliability varies, requiring cautious interpretation. 2 3

Management

Surgical Intervention: Urgent surgical repair of the perforation is often necessary.

Supportive Care: Fluid resuscitation, antibiotic therapy to prevent sepsis, and management of metabolic disturbances.

Drug Review: Careful review and potential discontinuation of the implicated drug under multidisciplinary guidance. 3

Special Populations

Neonates: Higher vulnerability to ADRs, especially with off-label drug use; causality assessment tools need adaptation for reliable evaluation. 3 5

Key Recommendations

Utilize Adapted Causality Assessment Tools: Given the variability in reliability, neonatal-specific adaptations of causality assessment tools are crucial for accurate evaluation of ADRs. (Evidence: Moderate 3)

Enhance Reporting Mechanisms: Improve reporting of suspected ADRs in neonates through education and cultural shifts to ensure clinical practice improvements. (Evidence: Expert opinion 5)

Surgical Intervention for Perforation: Prompt surgical intervention is essential for managing intestinal perforations to mitigate severe complications. (Evidence: Moderate 3)

References

1 Leopoldino RW, Rocha LCA, Fernandes FEM, de Lima Costa HTM, Vale LMP, Oliveira AG et al.. Assessment of severity and avoidability of adverse drug reactions in neonates: a reproducibility study of the Hartwig tool and LAAT. European journal of clinical pharmacology 2025. link 2 Leopoldino RWD, de Oliveira LVS, Fernandes FEM, de Lima Costa HTM, Vale LMP, Oliveira AG et al.. Causality assessment of adverse drug reactions in neonates: a comparative study between Naranjo's algorithm and Du's tool. International journal of clinical pharmacy 2023. link 3 Roberts EK, Hawcutt DB, Turner MA. Prospective identification and causality evaluation of suspected adverse drug reactions in neonates. British journal of clinical pharmacology 2021. link 4 Hawcutt DB, Russell NJ, Maqsood H, Kouranloo K, Gomberg S, Waitt C et al.. Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001-2010: content and utility analysis. British journal of clinical pharmacology 2016. link 5 Hawcutt DB, O'Connor O, Turner MA. Adverse drug reactions in neonates: could we be documenting more?. Expert review of clinical pharmacology 2014. link 6 Temple ME, Robinson RF, Miller JC, Hayes JR, Nahata MC. Frequency and preventability of adverse drug reactions in paediatric patients. Drug safety 2004. link

Neonatal perforation of intestine caused by drug