Adverse reactions in children during long-term antimicrobial therapy

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M Uhari1, M Nuutinen, J Turtinen

  • 1Department of Pediatrics, University of Oulu, Finland. Matti.Uhari@Oulu.fi

The Pediatric Infectious Disease Journal
|May 1, 1996
PubMed

Insights

Nitrofurantoin and sulfonamides are safe for long-term preventive antimicrobial therapy in children. Adverse reactions were uncommon and not serious, with most occurring within the first six months of treatment.

Area of Science:

  • Pediatric Pharmacology
  • Infectious Diseases
  • Drug Safety

Background:

  • Assessing adverse drug reactions (ADRs) in long-term antimicrobial therapy is crucial but challenging.
  • Data on ADRs for commonly used antimicrobial drugs are scarce.

Purpose of the Study:

  • To evaluate the incidence and nature of adverse reactions in children receiving long-term antimicrobial prophylaxis.
  • To compare the safety profiles of nitrofurantoin and sulfonamides in pediatric patients.

Main Methods:

  • Retrospective analysis of 16,409 children under 16 years old treated between 1976-1985.
  • Focus on 1825 children receiving long-term antimicrobial therapy for recurrent urinary tract infections.
  • Detailed review of adverse reactions reported during treatment courses.

Main Results:

  • 10.4% of treatment courses (589/5673) reported adverse reactions; 8.2% (463/5673) led to discontinuation.
  • Most common ADRs: nausea/vomiting with nitrofurantoin (4.4/100 PYAR), allergic skin reactions with sulfonamides (4.6/100 PYAR).
  • Younger children (<2 years) had more ADRs with nitrofurantoin; older children (2-15 years) had more treatment discontinuations with sulfonamides.

Conclusions:

  • Nitrofurantoin and sulfonamides demonstrate a favorable safety profile for long-term preventive antimicrobial use in children.
  • No serious or life-threatening reactions were observed.
  • ADRs primarily occurred within the initial six months of therapy.
Abstract

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