Table 4.
Description of suspected drugs (from main ATC groups reported) involved in child deaths on Notivisa between 2008-2013.
| Suspected Drug | ICD Classification (drug indication) | Total reports by drugs (n)/OL or UL* use (n) | Main events1 classified by System Organ Class |
|---|---|---|---|
| A - Alimentary tract and metabolism | 26 (12) | ||
| Alfaglicosidase | Glycogen storage disease | 3 (0) | Cardiovascular/Respiratory |
| Calcium gluconate | Not reported | 1 (0) | General disorders |
| Imiglucerase | Lipid deposit disorders | 3 (0) | General disorders/Respiratory |
| Laronidase | Mucopolysaccharidosis type I | 6 (0) | General disorders/Cardiovascular/Respiratory |
| Metoclopramide | Nausea and vomiting | 3 (3) | Blood/Cardiovascular |
| Miglustat | Not reported | 9 (8) | General disorders/Gastro-intestinal system/Neurologic/Respiratory |
| Ondansetron | Nausea and vomiting | 1(1) | Cardiovascular |
| J - Anti-infectives for systemic use | 18 (4) | ||
| Ampiciline | Not reported | 3 (0) | Neurologic |
| Benzylpenicillin | Not reported | 1 (0) | Neurologic |
| Caspofungin | Localized infections of the skin and subcutaneous tissue | 1 (1) | General disorders |
| Ceftriaxone | Acute upper airway infection | 1 (1) | Respiratory |
| Imipenem/Cilastatin | Complications of heart defects; Bacterial pneumonia; Infections due to other mycobacteria; Other bacterial diseases; Unspecified microorganism pneumonia | 8 (2) | Blood/General disorders/Cardiovascular/Endocrine/Gastro-intestinal/Musculo-skeletal system/Neurologic/Respiratory system/Urinary |
| Imunoglobuline (human) | Not reported | 1 (0) | Cardiovascular |
| Meropenem | Not reported | 1 (0) | Neurologic |
| Metronidazole | Other venous embolism and thrombosis | 1 (0) | Blood |
| Oxacillin | Not reported | 1 (0) | Skin |
| L - Antineoplastic and immunomodulating agents | 19 (14) | ||
| Carboplatin | Not reported | 1 (1) | General disorders |
| Carmustine + Cytarabine + Etoposide + Melphalan | Not reported | 4 (4) | Cardiovascular |
| Clofarabine | Lymphoid leukemia | 8 (8)* | Blood/General disorders/Cardiovascular/Respiratory |
| Ifosfamide | Not reported | 2 (0) | Gastro-intestinal |
| Methotrexate | Not reported | 2 (0) | Blood/General disorders/Cardiovascular/Gastro-intestinal system/Neurologic/Respiratory/Skin |
| Rituximab | Adverse effects of primarily systemic action substances | 1 (1) | Endocrine |
| Vincristine | Lymphoid leukemia | 1 (0) | General disorders |
ATC, Anatomical Therapeutic Chemical Code; ICD, International Classification of Diseases; OL, Off-label; UL*, Unlicensed use; Not reported, no information about drug indication on database.