Table 1 Analyses of characteristics reported in the pre-warning, warning and post-warning period
Pre-warning period 1978–2003 | Warning period 2004–2008 | Post-warning period 2009–2019 | |
|---|---|---|---|
Number of confirmed reports referring to suicidalitya | 11 (3.0%) | 61 (16.9%) | 290 (80.1%) |
Demographic parameters of the patients | |||
Mean age | 19.6 | 18.5 | 18.0 |
Median age | 20.0 | 18.0 | 18.0 |
Female | 63.6% (n = 7) | 57.4% (n = 35) | 69.3% (n = 201) |
Male | 36.4% (n = 4) | 41.0% (n = 25) | 29.7% (n = 86) |
Unknown | 0.0% (n = 0) | 1.6% (n = 1) | 1.0% (n = 3) |
Reported type of suicidalityb | |||
Suicidal ideation | 18.2% (n = 2) | 41.0% (n = 25) | 52.4% (n = 152) |
Suicide attempt | 81.8% (n = 9) | 52.5% (n = 32) | 46.6% (n = 135) |
Self-injury | 0.0% (n = 0) | 9.8% (n = 6) | 14.8% (n = 43) |
Overdose | 0.0% (n = 0) | 8.2% (n = 5) | 8.3% (n = 24) |
Median time to onset of suicidality [in days]c | |||
Suicidal ideation | 62.5 | 20.5 | 11.0 |
Suicide attempt | 24.5 | 23.0 | 31.0 |
Drugs reported as suspected with their median dose at time of reaction [in mg]d | |||
Citalopram | 18.2% (n = 2), 25 mg | 16.4% (n = 10), 20 mg | 17.9% (n = 52), 20 mg |
Escitalopram | 9.1% (n = 1), 10 mg | 19.7% (n = 12), 10 mg | 16.6% (n = 48), 10 mg |
Fluoxetine | 45.5% (n = 5), 20 mg | 31.1% (n = 19), 20 mg | 27.6% (n = 80), 20 mg |
Paroxetine | 18.2% (n = 2), 10 mg | 16.4% (n = 10), 20 mg | 5.2% (n = 15), 20 mg |
Sertraline | 9.1% (n = 1), 20 mg | 14.8% (n = 9), 50 mg | 32.4% (n = 94), 50 mg |
Fluvoxamine | 0.0% (n = 0), - | 1.6% (n = 1), 300 mg | 1.0% (n = 3), 22.5 mg |
Reported indicatione | |||
Depression | 81.8% (n = 9) | 67.2% (n = 41) | 64.1% (n = 186) |
Anxiety disorder | 18.2% (n = 2) | 8.2% (n = 5) | 14.1% (n = 41) |
History of suicidalityf | |||
Suicidal ideations | 9.1% (n = 1) | 11.5% (n = 7) | 9.0% (n = 26) |
Suicide attempts | 18.2% (n = 2) | 13.1% (n = 8) | 7.9% (n = 23) |
Self-injuries | 0.0% (n = 0) | 8.2% (n = 5) | 5.5% (n = 16) |
Seriousness of reportsg | |||
Serious | 100.0% (n = 11) | 100.0% (n = 61) | 95.2% (n = 276) |
Death | 36.4% (n = 4) | 16.4% (n = 10) | 13.1% (n = 38) |
Life-threatening | 9.1% (n = 1) | 29.5% (n = 18) | 26.2% (n = 76) |
Hospitalization | 36.4% (n = 4) | 39.3% (n = 24) | 37.2% (n = 108) |
Disabling | 9.1% (n = 1) | 3.3% (n = 2) | 6.9% (n = 20) |
Primary reporting sourceh | |||
Physician | 81.8% (n = 9) | 65.6% (n = 40) | 43.4% (n = 126) |
Pharmacist | 9.1% (n = 1) | 6.6% (n = 4) | 5.5% (n = 16) |
Other healthcare professionals | 9.1% (n = 1) | 8.2% (n = 5) | 7.2% (n = 21) |
Patients | 0.0% (n = 0) | 8.2% (n = 5) | 36.6% (n = 106) |