Table 1 ICSRs in children (<15 years old) and adults (≥15 years old) during 2005.
From: Individual case safety reports in children in commonly used drug groups – signal detection
Children | Adults | ||||||||
|---|---|---|---|---|---|---|---|---|---|
ATC code | Name of group | ICSR (n) | Serious ADR (n) | Million DDD (n) | ICSR per million DDD (95% CI) | ICSR (n) | Serious ADR (n) | Million DDD (n) | ICSR per million DDD (95% CI) |
R03DC | Leukotriene receptor antagonists | 16 | 0 | 0.7 | 24 (13.6 – 38.6) | 7 | 0 | 5.2 | 1.4 (0.5 – 2.8) |
N06BA | Centrally acting sympathomimetics | 12 | 0 | 1.5 | 7.8 (4.0 – 13.6) | 15 | 2 | 2.6 | 5.7 (3.2 – 9.5) |
H02AB | Glucocorticoids | 3 | 0 | 0.7 | 4.5 (0.9 – 13.0) | 31 | 21 | 32 | 1.0 (0.7 – 1.4) |
H01BA | Vasopressin and analogues | 3 | 0 | 1.1 | 2.8 (0.6 – 8.2) | 5 | 2 | 1.3 | 3.9 (1.3 – 9.2) |
N03AX | Other antiepileptics | 1 | 0 | 0.4 | 2.4 (0.1 – 13.1) | 58 | 19 | 9.7 | 6.0 (4.5 – 7.7) |
R03CC | Selective beta-2-adrenoreceptor agonists | 1 | 0 | 0.4 | 2.3 (0.1 – 12.6) | 1 | 1 | 1.4 | 0.7 (0.02–3.9) |
J01CA | Penicillins with extended spectrum | 1 | 0 | 0.5 | 2.1 (0.1 – 11.5) | 12 | 3 | 3.9 | 3.1 (1.6 – 5.4) |
R05FA | Opium derivatives and expectorants | 1 | 1 | 0.5 | 2.0 (0.1 – 11.4) | 1 | 0 | 11 | 0.1 (0.002 – 0.5) |
J01CE | Beta-lactamase sensitive penicillins | 3 | 0 | 1.6 | 1.8 (0.4 – 5.3) | 14 | 5 | 11 | 1.3 (0.7 – 2.1) |
A10AE | Insulins and analogues. long-acting | 1 | 0 | 0.7 | 1.5 (0.04–8.5) | 7 | 2 | 11 | 0.6 (0.3 – 1.3) |
R06AX | Other antihistamines for systemic use | 5 | 1 | 3.4 | 1.5 (0.5 – 3.5) | 14 | 3 | 31 | 0.5 (0.3 – 0.8) |
H01AC | Somatropin and somatropin agonists | 1 | 0 | 0.8 | 1.3 (0.03–7.1) | 2 | 0 | 0.8 | 2.6 (0.3 – 9.5) |
R03BA | Glucocorticoids, inhalants | 4 | 0 | 3.6 | 1.1 (0.3 – 2.8) | 5 | 0 | 37 | 0.1 (0.04 – 0.3) |
R03AK | Adrenergics and other drugs for obstructive airway diseases | 2 | 0 | 2.0 | 1.0 (0.1 – 3.7) | 10 | 1 | 33 | 0.3 (0.1 – 0.6) |
R05CB | Mucolytics | 1 | 0 | 1.2 | 0.8 (0.02–4.5) | 3 | 1 | 28 | 0.1 (0.02 – 0.3) |
R06AE | Piperazine derivatives | 1 | 0 | 1.5 | 0.7 (0.02–3.8) | 3 | 1 | 19 | 0.2 (0.03 – 0.5) |
R03AC | Selective beta-2-adrenoreceptor agonists | 2 | 1 | 4.4 | 0.5 (0.1 – 1.7) | 5 | 0 | 49 | 0.1 (0.03 – 0.2) |
D07AA | Corticosteroids. weak (group I) | 1 | 0 | 4.9 | 0.2 (0.01 – 1.1) | 0 | 0 | 6.3 | 0.0 (-0.6)1 |
D02AX | Other emollients and protectives | 1 | 0 | 53 | 0.02 (0.001 – 0.1) | 0 | 0 | 149 | 0 (-0.02)1 |