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Adverse Drug Reactions in Patients Receiving Systemic Antifungal Therapy at a High-Complexity Hospital

Maria Clara Padovani de Souza1,2, Andrezza Gouvêa Dos Santos1,2, Adriano Max Moreira Reis1,2

  • 1Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brasil.

Journal of Clinical Pharmacology
|May 21, 2016
PubMed

Insights

Adverse drug reactions (ADRs) from systemic antifungal drugs affect 29% of hospitalized patients. Neoplasm diagnosis, longer hospital stays, and polypharmacy increase ADR risk, necessitating improved antifungal stewardship.

Area of Science:

  • Pharmacovigilance
  • Infectious Diseases
  • Oncology

Background:

  • Systemic antifungal drugs are crucial for treating serious fungal infections.
  • Adverse drug reactions (ADRs) can complicate antifungal therapy, impacting patient outcomes.
  • Identifying risk factors for ADRs is essential for optimizing antifungal use.

Purpose of the Study:

  • To determine the frequency of ADRs associated with systemic antifungal drugs in hospitalized patients.
  • To investigate factors contributing to the occurrence of these ADRs.

Main Methods:

  • Cross-sectional retrospective study of 183 patient medical records.
  • Antifungal drug classification using Anatomical Therapeutic Chemical (ATC) System.
  • ADR causality assessment via Naranjo algorithm and drug interaction analysis using DRUG-REAX.
  • Statistical analysis including descriptive statistics and logistic regression.

Main Results:

  • 29.0% of patients experienced at least one antifungal-related ADR, with 96 ADRs detected overall.
  • Common ADRs included infusion reactions (25.0%), hypokalemia (22.9%), nephrotoxicity (18.7%), and hepatotoxicity (15.6%).
  • Amphotericin B and voriconazole were linked to significant ADRs. Neoplasm diagnosis (OR 3.9), extended hospital stay (OR 2.2), and polypharmacy (≥13 drugs, OR 3.4) were independent risk factors for ADRs.

Conclusions:

  • Systemic antifungal therapy is associated with a significant ADR frequency in hospitalized patients.
  • Neoplasm diagnosis, prolonged hospitalization, and concomitant use of multiple medications are key risk factors for antifungal-induced ADRs.
  • These findings underscore the need for enhanced antifungal stewardship programs to mitigate risks and ensure rational drug use.
Keywords:
adverse drug reactionantifungal agentsantifungal therapydrug interactiondrug utilization

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