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European Journal of Clinical Pharmacology

, Volume 62, Issue 5, pp 343–346 | Cite as

Reported adverse drug reactions during the use of inhaled steroids in children with asthma in the Netherlands

  • T. W. de VriesEmail author
  • J. J. de Langen-Wouterse
  • E. van Puijenbroek
  • E. J. Duiverman
  • L. T. W. de Jong-Van den Berg
Pharmacodynamics

Abstract

Objectives

Inhaled corticosteroids (ICS) are widely used in the treatment of asthma. We studied the suspected adverse drug reactions (sADRs) reported during the use of ICS in the Netherlands.

Methods

In the Netherlands, health professionals and patients can report suspected ADRs to the Pharmacovigilance Centre Lareb. All reported sADRs on ICS were categorised and assessed as to whether these were likely to be associated with use of the steroid. Age and gender adjusted Reported Odds Ratios (RORs) and Naranjo Scores (NS) were computed for sADRs reported more than 3 times.

Results

Since 1984, sADRs of ICS were reported in 89 children (mean age 6 years), 48 (54%) were boys. Suspected drugs were fluticasone in 46 children (52%), budesonide in 21 (24%), and beclomethasone in 22 cases (24%). Psychiatric symptoms were reported in 19 children (21%; ROR 3.8, NS 3.6), growth retardation in 6 children (7%; ROR 47.8, NS 3.0) and rashes in 6 cases (7%; ROR 0.7, NS 2.4). There were 7 reports (8%; ROR 2.1, NS 3.4) concerning abnormalities of the teeth, 4 reports of alopecia (4%; ROR 3.3, NS 3.5), and 3 reports of hirsutism and hypertrichosis (NS 4.0). Non-fatal adrenal insufficiency was reported once.

Conclusions

Alteration of behaviour was the most frequently reported sADR. There are more indications that alterations of behaviour could be a real sADR of ICS. Non-fatal adrenal insufficiency was the only reported possible life threatening sADR. The association of hypertrichosis and teeth abnormalities after ICS in children has not been reported in the literature before.

Keywords

Inhaled corticosteroids Naranjo scores Reported odds ratios Suspected adverse drug reactions 

Notes

Acknowledgement

We thank Dr. J. Collins for reviewing the English.

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Copyright information

© Springer-Verlag 2006

Authors and Affiliations

  • T. W. de Vries
    • 1
    Email author
  • J. J. de Langen-Wouterse
    • 2
  • E. van Puijenbroek
    • 2
  • E. J. Duiverman
    • 3
  • L. T. W. de Jong-Van den Berg
    • 4
  1. 1.Department of PediatricsMedical Centre LeeuwardenLeeuwardenThe Netherlands
  2. 2.Netherlands Pharmacovigilance Centre Lareb’s-HertogenboschThe Netherlands
  3. 3.Department of Paediatric PulmonologyUniversity HospitalGroningenThe Netherlands
  4. 4.Department of Social Pharmacy, Pharmacoepidemiology and PharmacotherapyGroningen University Institute for Drug ExplorationGroningenThe Netherlands

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