Reported adverse drug reactions during the use of inhaled steroids in children with asthma in the Netherlands.
OBJECTIVE
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.
Department of Pediatrics, Medical Centre Leeuwarden, P.O. Box 888, 8901 BR Leeuwarden, The Netherlands. tjalling.de.vries@znb.nl
T W
TW
de Vries
J J
JJ
de Langen-Wouterse
E
E
van Puijenbroek
E J
EJ
Duiverman
L T W
LT
de Jong-Van den Berg
D000280:Administration, Inhalation; D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D005260:Female; D000068298:Fluticasone; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D009426:Netherlands
D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D005938:Glucocorticoids; D019819:Budesonide; D000068298:Fluticasone; D001507:Beclomethasone