Table 4.
ROR for hepatic injury by therapeutic class*
Therapeutic classes | ATC code (II level) | Number of cases (% on 6595) | Drug | Adjusted† RORs within therapeutic class (95% CI) |
---|---|---|---|---|
Antiepileptics | N03 | 762 (12) | Sulthiame | 3.6 (1.6, 7.9) |
Ethosuximide | 2.8 (1.6, 4.9) | |||
Phenobarbital | 2.0 (1.4, 2.9) | |||
Valproic acid | 1.5 (1.3, 1.8) | |||
Carbamazepine | 1.3 (1.0, 1.5) | |||
Antibacterials | J01 | 742 (11) | Aztreonam | 5.9 (2.2, 15.4) |
Loracarbef | 3.9 (1.5, 10.1) | |||
Erythromycin | 3.4 (1.2, 10.0) | |||
Ceftriaxone | 3.1 (2.5, 3.8) | |||
Josamycin | 2.9 (1.5, 5.7) | |||
Minocycline | 2.7 (2.1, 3.6) | |||
Analgesics | N02 | 472 (7) | Paracetamol | 5.6 (4.5, 6.9) |
Paracetamol/hydrocodone | 1.8 (1.1, 3.0) | |||
Psychoanaleptics | N06 | 457 (7) | Pemoline‡ | 30.7 (23.3, 40.6) |
Nefazodone | 7.3 (4.3, 12.4) | |||
Atomoxetine | 1.7 (1.3, 2.3) | |||
Antineoplastics | L01 | 421 (6) | Mercaptopurine | 4.2 (3.0, 6.0) |
Gemtuzumab | 4.2 (2.9, 5.9) | |||
Tioguanine | 3.9 (2.7, 5.7) | |||
Methotrexate | 3.2 (2.0, 5.3) | |||
Antivirals | J05 | 397 (6) | Atazanavir | 21.5 (11.3, 41.0) |
Emtricitabine | 6.4 (2.0, 21.0) | |||
Lamivudine | 1.7 (1.3, 2.4) | |||
Zidovudine | 1.5 (1.1, 1.9) | |||
Psycholeptics | N05 | 287 (4) | Chlorprothixene | 4.8 (1.6, 14.2) |
Olanzapine | 3.5 (2.6, 4.7) | |||
Immunosuppressants | L04 | 251 (4) | Basiliximab | 2.6 (1.6, 4.2) |
Ciclosporin | 1.4 (1.0, 1.9) | |||
Antimycobacterials | J04 | 120 (2) | Pyrazinamide | 2.3 (1.2, 4.4) |
Isoniazid | 2.1 (1.3, 3.2) | |||
Sex hormones | G03 | 115 (2) | Norethisterone/ethinylestradiol | 24.5 (6.4, 93.6) |
Estradiol | 6.7 (2.0, 22.1) | |||
Norethisterone | 5.8 (2.5, 13.5) | |||
Ethinylestradiol/levonorgestrel | 2.1 (1.4, 3.2) | |||
Antimycotics | J02 | 107 (2) | Voriconazole | 1.9 (1.2, 3.0) |
For each therapeutic class, only those drugs with statistically significant adjusted RORs for hepatic injury have been reported.
Only therapeutic classes with at least 100 cases have been considered in this analysis.
Adjusted for age, gender, country of reporting and type of reporter.
Drug withdrawal from the market because of hepatotoxicity.