|
ICSRs in children (<15 years old) and adults (≥15 years old) during 2005. |
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| Children |
Adults |
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|
|
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| 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) |
|
|
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| 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 |
|
ADR, adverse drug reaction; CI, confidence interval; DDD, defined daily dose; ICSR, individual case safety report 1one-sided 97.5% CI | |||||||||
Brunlöf et al. BMC Clinical Pharmacology 2008 8:1 doi:10.1186/1472-6904-8-1 |
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