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Adverse drug reaction profile of oseltamivir in children

Prashant S Dalvi1, Anil Singh, Hiren R Trivedi

  • 1Department of Pharmacology, MP Shah Medical College, Jamnagar 361 008, Gujarat, India.

Journal of Pharmacology & Pharmacotherapeutics
|July 21, 2011
PubMed

Insights

Oseltamivir is well-tolerated in Indian children with H1N1 influenza, with common adverse drug reactions including vomiting and diarrhea. The study confirms the safety of oseltamivir, even in infants.

Area of Science:

  • Pediatric Pharmacology
  • Infectious Diseases
  • Clinical Pharmacy

Background:

  • Influenza A (H1N1) virus infections pose a significant health risk to pediatric populations.
  • Oseltamivir is a widely used antiviral medication for influenza treatment and prophylaxis in children.
  • Understanding the adverse drug reaction (ADR) profile of oseltamivir in pediatric H1N1 cases is crucial for clinical practice.

Purpose of the Study:

  • To monitor and evaluate the pattern of adverse drug reactions (ADRs) associated with oseltamivir use.
  • To assess the safety and tolerability of oseltamivir in pediatric patients diagnosed with H1N1 influenza.
  • To analyze the incidence, severity, and causality of ADRs in different age groups within the pediatric population.

Main Methods:

  • A prospective study involving 191 pediatric patients treated with oseltamivir for H1N1 influenza.
  • Adverse events were monitored through direct questioning and clinical examinations on days 5 and 10.
  • Neurological events were specifically assessed by querying parents/guardians, with ADRs analyzed for severity, causality, and age-specific incidence.

Main Results:

  • 69 out of 191 children (36.1%) experienced ADRs, with vomiting (16.2%) and diarrhea (12.0%) being the most frequent.
  • Neuropsychiatric symptoms occurred in 12.6% of cases and were generally mild-to-moderate.
  • No significant difference in ADR incidence was observed between infants (<1 year) and older children.

Conclusions:

  • Oseltamivir demonstrates good tolerability in Indian pediatric patients with H1N1 influenza.
  • The findings support the safety profile of oseltamivir, including its use in infants.
  • This study provides valuable data on oseltamivir's ADR patterns in a key pediatric demographic.
Abstract

Keywords:
Adverse drug reactionsantiviral agentchildinfantoseltamivir

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