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[How often do SmPCs Contain Contraindications and Special Warnings that are Specific for the Paediatric Population]

Stefan Wimmer1,2, Wolfgang Rascher1, Antje Neubert1

  • 1Department of Paediatrics and Adolescent Medicine, Universitätsklinikum, Erlangen.

Klinische Padiatrie
|June 4, 2019
PubMed

Insights

Many medicines have contraindications for pediatric patients due to lack of data, not inherent risks. The EU Paediatric Regulation has not significantly increased pediatric studies for off-patent drugs.

Area of Science:

  • Pharmacovigilance
  • Pediatric Pharmacology
  • Drug Safety

Background:

  • Off-label prescribing is common in pediatric patients, with many medications lacking age-specific licensing.
  • A significant proportion of commonly used drugs for newborns are not approved for this age group.

Purpose of the Study:

  • To analyze German Summary of Product Characteristics (SmPCs) for contraindications and warnings specific to pediatric age groups.
  • To identify patterns in these contraindications based on age, drug class, and route of administration.

Main Methods:

  • Systematic review of all available German SmPCs.
  • Extraction and evaluation of information on pediatric age groups from 'Contraindications' and 'Special warnings and precautions' sections.
  • Analysis of results by age group, Anatomical Therapeutic Chemical (ATC) classification, and route of application.

Main Results:

  • Out of 13,547 SmPCs reviewed, 15.8% contained contraindications for at least one pediatric age group.
  • 42.4% of medicinal products had contraindications or warnings for pediatric patients, with 12.4% affecting all patients under 18.
  • Preterm infants were particularly affected (41.9%), as were contrast media (89.0%), cough and cold preparations (86.2%), and corticosteroids (88.2% topical, 86.6% systemic).

Conclusions:

  • Pediatric contraindications in SmPCs likely stem from insufficient data and lack of age-specific formulations, rather than pharmacokinetic/pharmacodynamic differences.
  • The EU Paediatric Regulation has had a limited impact on encouraging pediatric studies for off-patent medicines.
Abstract

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