Table 1.
Summary of all individual case safety reports (ICSRs) related to (suspect or interacting) oxytocin and carbetocin within VigiBase, the World Health Organization’s database for ICSRs
| Oxytocin (%) | Carbetocin (%) | |
|---|---|---|
| Total ICSR | 11,258 (100) | 374 (100) |
| Total reactions | 21,274 (100) | 700 (100) |
| Patients | ||
| Age [y] | ||
| Mean (SD) | 29.4 (8.4) | 31.2 (7.5) |
| Under 1 | 177 (1.6) | 5 (1.3) |
| 1–14 | 24 (0.2) | 1 (0.3) |
| 15–24 | 1 774 (15.8) | 29 (7.8) |
| 25–34 | 4 933 (43.8) | 185 (49.5) |
| 35–44 | 1 622 (14.4) | 96 (25.7) |
| 45–54 | 258 (2.3) | 2 (0.5) |
| Over 55 | 47 (0.4) | 1 (0.3) |
| Not reported | 2 433 (21.5) | 55 (14.7) |
| Sex | ||
| Female | 10,402 (92.4) | 368 (98.4) |
| Not reported | 656 (5.8) | 4 (1.1) |
| Reports | ||
| Additional drugs | ||
| Mean (SD) | 0.9 (1.9) | 1.3 (2.5) |
| Range | 0–30 | 0–18 |
| Additional uterotonics* | ||
| Mean (SD) | 0.1 (0.4) | 0.2 (0.6) |
| Range | 0–7 | 0–4 |
| Most common concomitant drugs | ||
| Glucose | 945 (8.4) | 9 (2.4) |
| Sodium chloride | 941 (8.4) | 23 (6.1) |
| Dinoprostone | 524 (4.7) | 1 (0.3) |
| Misoprostol | 520 (4.6) | 8 (2.1) |
| Bupivacaine | 332 (2.9) | 10 (2.7) |
| Fentanyl | 287 (2.5) | 16 (4.3) |
| Ringer’s solution | 193 (1.7) | 11 (2.9) |
| Cefazolin | 161 (1.4) | 19 (5.1) |
| Paracetamol | 109 (1.0) | 7 (1.9) |
| Propofol | 105 (0.9) | 2 (0.5) |
| Carboprost | 76 (0.7) | 20 (5.3) |
| Sufentanil | 72 (0.6) | 16 (4.3) |
| Ephedrine | 71 (0.6) | 15 (4.0) |
| Oxytocin | n.a | 60 (16.0) |
| Carbetocin | 31 (0.3) | n.a |
| Not coded | 458 (4.1) | 19 (5.1) |
| Origin of report | ||
| Africa | 159 (1.4) | 14 (3.7) |
| America | 1 446 (12.8) | 31 (8.3) |
| Asia | 6 929 (61.5) | 219 (58.6) |
| Europe | 2 292 (20.4) | 90 (24.4) |
| Oceania | 417 (3.7) | 20 (5.3) |
| Not reported | 15 (0.1) | 0 (0.0) |
| Serious | ||
| Yes | 3 412 (30.3) | 145 (38.8) |
| No | 6 426 (57.1) | 184 (49.2) |
| Not reported | 1 420 (12.6) | 45 (12.0) |
| Fatal | ||
| Yes | 164 (1.5) | 3 (0.8) |
*Uterotonics included: “Methylergometrine”, “Ergot alkaloids”, “Ergometrine”, “Dinoprostone”, “Gemeprost”, “Carboprost”, “Sulprostone”, “Misoprostol”