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.
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References
Agertoft L, Pedersen S (2000) Effect of long-term treatment with inhaled budesonide on adult height in children with asthma. N Engl J Med 343:1064–1069
Anonymous (1997) Asthma in adults and schoolchildren. The General Practitioner in Asthma Group, the British Association of Accident and Emergency Medicine, The British Paediatric Respiratory Society and the Royal College of Paediatrics and Child Health. Thorax 52(suppl 1):s2–s8
Anonymous (1997) Asthma in children under five years of age. The General Practitioner in Asthma Group, the British Association of Accident and Emergency Medicine, The British Paediatric Respiratory Society and the Royal College of Paediatrics and Child Health. Thorax 52(suppl 1):s9–s20
Anonymous (2000) Corticotrophins and corticosteroids. In: Dukes MGN, Aronson JK (eds) Meyler’s side effects of drugs. Elsevier, Amsterdam pp 1369–1389
Anonymous (2003) Review of systemic adverse effects associated with corticosteroids http://thomsonhc.com/micromedex.com
Bender BC, Ikle DN, DuHamel T, Tinkelman D (1998) Neuropsychological and behavioral changes in asthmatic children treated with beclomethasone dipropionate versus theophylline. Pediatrics 101:355–360
Calam R, Gregg L, Simpson A, Simpson B, Woodcock A, Custovic A (2005) Behavior problems antecede the development of wheeze in childhood. Am J Respir Crit Care Med 171:323–327
Clarkson A, Choonara I (2002) Surveillance for fatal suspected adverse drug reactions in the UK. Arch Dis Childhd 87:462–466
Dubus JC, Marguet C, Deschildere A, Mely L, Le Roux P, Brouard J, Huiart L (2001) Local side-effects of inhaled corticosteroids in asthmatic children: influence of drug, dose, age, and device. Allergy 56:944–948
Elias PC, Sagua D, Alvarez EO (2004) Chronic aerial exposure to glucosteroids or beta-agonists affects avoidance learning and exploratory motivation in rats. Behav Brain Res 149:95–105
Global Initiative for Asthma (GINA) (2002) Global strategy for asthma management and prevention. National Institutes of Health. National Heart, Lung, and Blood Institute. Bethesda, Md., USA
Hadjikoumi I, Loader P, Bracken M, Milner AD (2004) Bronchodilator therapy and hyperactivity in preschool children. Arch Dis Childhood 86:202–203
Hanania NA, Chapman KR, Kesten S (1995) Adverse effects of inhaled corticosteroids. Am J Med 98:196–208
Hederos C (2004) Neuropsychologic changes and inhaled steroids. J Allergy Clin Immunol 114:451–452
Kayani S, Shannon DC (2002) Adverse behavioral effects of treatment for acute exacerbation of asthma in children. Chest 122:624–628
Lipworth BJ (1999) Systemic adverse effects of inhaled corticosteroid therapy: a systematic review and meta-analysis. Arch Intern Med 159:941–955
Mak VHF, Melchor R, Spiro SG (1992) Easy bruising as a side effect of inhaled corticosteroids. Eur Respir J 5:1068–1074
McQuaid EL, Kopel SJ, Nassau JH (2001) Behavioral adjustment in children with asthma: a meta-analysis. J Dev Behav Pediatr 22:430–439
Meyboom RH, de Graaf-Breederveld N (1988) Budesonide and psychic side effects. Ann Intern Med 109:683
Meyboom RH, Verduijn MM, Steenvoorden MG, Dekens-Konter JA, van Puijenbroek EP (1996) Reversible tooth discoloration during oral use of antibiotics. Ned Tijdschr Geneeskd 140:207–209
Moore N, Kreft-Jais C, Haramburu F, Noblet C, Andrejak M, Ollagnier M, Begaud B (1997) Reports of hypoglycaemia associated with the use of ACE inhibitors and other drugs: a case/non-case study in the French pharmacovigilance system database. Br J Clin Pharmacol 44:513–518
Naranjo CA, Busto U, Sellers, EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq, Greenblatt DJ (1981) A method for estimating the probability of adverse effects. Clin Pharmacol Ther 30:239–245
Todd GRC, Acerini CL, Ross-Russell R, Zahra S, Warner JT, McCance D (2002) Survey of adrenal crisis associated with inhaled corticosteroids in the United Kingdom. Arch Dis Child 87:457–461
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We thank Dr. J. Collins for reviewing the English.
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de Vries, T.W., de Langen-Wouterse, J.J., van Puijenbroek, E. et al. Reported adverse drug reactions during the use of inhaled steroids in children with asthma in the Netherlands. Eur J Clin Pharmacol 62, 343–346 (2006). https://doi.org/10.1007/s00228-006-0102-6
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DOI: https://doi.org/10.1007/s00228-006-0102-6