Table 1.
Analysis of promethazine abuse/misuse/dependence/withdrawal cases recorded by EudraVigilance (EV) during years 2003–2019.
| Individual cases (% of total within parentheses) | |
|---|---|
| Total abuse/misuse/dependence cases | 1543 Single cases; number of ADRs :11,796 |
| Age range | Adult (19–64 years): 648 (648/1,543: 42.0%) - mean age: 31.8 years (SD 26.55–37.05) |
| Adolescent (10–18 years): 23 (23/1,543: 1.5%) – mean age: 15.9 years (SD 14.3–17.77) | |
| Elderly (>65 years): 25 (25/1,543: 1.6%) – mean age: 72.3 years (SD 70.85–73.7) | |
| Neonatal (hours–days) 14 (14/1,543: 0.9%) – mean age: 24 h (SD 16.6–27.4) | |
| Infant (months–1 year): 7 (7/1,543: 0.45%) – mean age: 10 months (SD 7–13) | |
| Child (<10 years): 4 (4: 1,543: 0.35%) – mean age: 5 years (SD 3.6–6.3) | |
| Unknown: 822 (822/1,543: 53.2%) | |
| Male/female | 235/461: 0.51 |
| Most represented abuse/misuse/dependence-related ADRs according to the PTs: | 557 (557/1,543: 36.1%) |
| Abuse-related ADRs | 458 (458/557: 82.2%) |
| Drug abuse | 300 |
| Drug abuser | 15 |
| Drug diversion | 1 |
| Intentional product misuse | 117 |
| Intentional product use issue | 9 |
| Substance abuse | 11 |
| Substance abuser | 3 |
| Substance use | 2 |
| Dependence-related ADRs | 44 (44/557: 7.9%) |
| Dependence | 4 |
| Drug dependence | 39 |
| Substance dependence | 1 |
| Withdrawal-related ADRs | 55 (55/557: 9.8%) |
| Withdrawal syndrome | 19 |
| Drug withdrawal convulsions | 1 |
| Drug withdrawal neonatal syndrome | 18 |
| Drug withdrawal syndrome | 17 |
| Outcome | Fatal 310 (310/557: 55.6%) |
| Unknown 161 (161/557: 28.9%) | |
| Recovered/resolved 55 (55/557: 9.9%) | |
| Recovering/resolving 18 (18/557: 3.3%) | |
| Not recovered/not resolved 13 (13/557: 2.3%) | |
| Promethazine-cases alone | 74 (with maximum dosage 2500 mg) |
| Promethazine-cases with other drugs | Most cases (122) were over 100 mg (with maximum dosage 8000 mg) |
| Most common psychoactive substances used | Alcohol: 114 |
| Cocaine: 68 | |
| Cannabis: 16 | |
| Ketamine: 4 | |
| Amphetamine: 1 | |
| Most common prescription drugs used | Opioids: 1187 |
| Benzodiazepines: 914 | |
| Antidepressants: 871 | |
| Antipsychotics: 437 | |
| Z-drugs: 222 | |
| Mood stabilisers: 197 |
ADR: adverse drug reaction; PTs: preferred terms; SD: standard deviation.