Table 5 Suspected drugs associated with liver injury in children but not labeled as such in medicine specifications
Drug (ATC code-5th level) | Number of reports | PRR | χ² | ROR (95% CI) | Metabolized via the liver | Hepatoxicity in prescribing information |
|---|---|---|---|---|---|---|
Acetylcysteine (R05CB01) | 19 | 2.8 | 20.3 | 3.0 (1.9–4.8) | Yes | No |
Thiopental (N05CA19) | 16 | 3.1 | 22 | 3.5 (2.0–5.9) | Yes | No |
Temazepam (N05CD07) | 9 | 2.2 | 5.3 | 2.4 (1.2–4.7) | Yes | No |
Nefopam (N02BG06) | 5 | 10.7 | 36.2 | 18.7 (5.7–61.3) | Yes | No |
Primaquine (P01BA03) | 5 | 9 | 29.3 | 14.0 (4.6–42.9) | Yes | No |
Pyrimethamine (P01BD01) | 4 | 3.1 | 4 | 3.5 (1.2–9.9) | Yes | No |