Table 1.
Analysis of suspect selective serotonin reuptake inhibitor (SSRI)-related adverse drug reactions reported to the European Medicines Agency (EMA) EudraVigilance (EV) dataset and the Food and Drug Administration (FDA) Adverse Event Reporting System.
| Citalopram | Escitalopram | Fluoxetine | Paroxetine | Sertraline | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| EMA | FAERS | EMA | FAERS | EMA | FAERS | EMA | FAERS | EMA | FAERS | |
| Individual Cases | 1419 | 25,744 | 404 | 18,235 | 771 | 22,793 | 1592 | 39,091 | 1149 | 38,532 |
| Mean Age in years (SD) | 42.6 (14.2) | 47.6 (21.5) | 43.3 (18.6) | 48.2 (22.5) | 43.1 (15.5) | 42.5 (20.6) | 41.4 (15.8) | 44.0 (23.5) | 41.6 (16.5) | 45.6 (22.0) |
| M/F (%) | 615/773 (44%/56%) |
8770/14,169 (38%/62%) | 138/244 (36%/64%) |
5988/10,920 (35%/65%) | 279/457 (38%/62%) |
6547/13,141 (33%/67%) |
554/959 (37%/63%) |
13,124/22,609 (37%/63%) |
493/606 (45%/55%) |
12,245/21,972 (36%/64%) |
| Most common psychiatric indications recorded for the index SSRI (%) | Depression (14.6) Drug abuse (3.2) Anxiety (2.6) |
Depression (38.7) Anxiety (9.4) |
Depression (51.0) Anxiety (12.9) Drug abuse (5.8) |
Depression (50.5) Anxiety (15.3) |
Depression (22.7) Drug abuse (4.1) Anxiety (3.4) |
Depression (43.4) Anxiety (7.6) Obsessive-compulsive disorder (2.7) |
Depression (38.1) Anxiety (14.8) Panic disorder/attack (6.5) | Depression (32.8) Anxiety (9.9) Generalised anxiety disorder (3.9) |
Depression (34.5) Anxiety (7.5) | Depression (44.8) Anxiety (15.1) |
| ROA (%) | Oral (68.4) Parenteral * (0.8) T-placent (0.7) Inhalation (0.2) NA (29.9) |
Oral (70.7) T-placent (8.3) Parenteral * (0.3) T-mam (0.2) NA (20.4) |
Oral (79.7) T-placent (2.5) NA (16.6) |
Oral (77.8) T-placent (6.3) T-mam (0.2) NA: (15.7) |
Oral (61.9) Inhalation (1.9) T-placent (1.7) Parenteral * (1.2) NA (33.2) | Oral (57.4) T-placent (15.0) T-mam (0.3) Parenteral * (0.2) NA (27.2) |
Oral (82.2) T-placent (1.4) Parenteral * (0.2) Inhalation (0.1) NA (16.0) |
Oral (74.7) T-placent (10.3) Parenteral * (0.1) NA (15.1) |
Oral (65.5) T-placent (2.2) Inhalation (0.5) Parenteral * (0.4) NA (30.9) |
Oral (69.4) T-placent (11.7) T-mam (0.3) NA (15.7) |
| Therapeutic regimen (Mono/Poly) | 139 (10%)/ 1280 (90%) |
1502 (6%)/ 24,242 (94%) |
131 (32%)/ 273 (68%) |
1260 (7%)/ 16,975 (93%) |
76 (10%)/ 695 (90%) |
1072 (5%)/ 21,721 (95%) |
537 (34%)/ 1055 (66%) |
3586 (9%)/ 35,505 (91%) |
197 (17%)/ 952 (83%) |
3365 (9%)/ 35,167 (91%) |
| Most important concomitant prescription psychotropic drugs recorded (%) | ||||||||||
| Antidepressants | 17.5 | 19.2 | 10.4 | 17.3 | 18.8 | 20.2 | 9.0 | 11.0 | 13.4 | 13.6 |
| Antihistamines | 25.4 | 9.0 | 3.2 | 5.7 | 19.3 | 8.5 | 10.8 | 4.6 | 17.5 | 6.5 |
| Antipsychotics | 13.7 | 17.1 | 16.1 | 19.0 | 19.3 | 18.7 | 9.5 | 9.8 | 13.2 | 15.8 |
| Benzodiazepines ° | 36.9 | 22.8 | 28.7 | 23.8 | 43.3 | 20.4 | 27.6 | 17.2 | 29.9 | 16.4 |
| Gabapentinoids | 2.5 | 5.0 | 4.5 | 4.2 | 4.2 | 4.8 | 2.3 | 2.0 | 3.7 | 4.7 |
| Mood Stabilizers | 3.0 | 8.4 | 7.2 | 10.3 | 5.4 | 9.2 | 3.7 | 5.4 | 7.0 | 7.0 |
| Opioids | 59.7 | 22.7 | 10.9 | 11.0 | 43.3 | 16.4 | 16.0 | 7.1 | 40.7 | 11.1 |
| Z-Drugs | 3.4 | 6.3 | 4.5 | 6.8 | 9.3 | 5.6 | 8.2 | 4.8 | 5.6 | 4.5 |
| Most important concomitant recreational drugs recorded (%) | ||||||||||
| Alcohol | 13.5 | 4.3 | 2.7 | 1.7 | 14.8 | 3.1 | 3.5 | 1.4 | 7.1 | 1.3 |
| Amphetamines | 2.4 | 1.1 | 1.5 | 0.7 | 3.1 | 1.2 | 0.5 | 0.3 | 3.3 | 0.7 |
| Cannabis and Cannabinoids | 1.2 | 0.6 | 1.7 | 0.4 | 1.3 | 0.4 | 0.5 | 0.2 | 1.2 | 0.3 |
| Cocaine | 9.4 | 1.5 | 2.2 | 0.4 | 4.9 | 0.6 | 1.0 | 0.2 | 9.8 | 0.6 |
| Heroin | 0 | 1.8 | 0 | 0 | 0 | 0.5 | 0 | 0.1 | 0 | 0.5 |
| Ketamine | 0.2 | 0 | 0 | 0 | 0.4 | 0 | 0 | 0 | 0 | 0 |
Abbreviations: EMA: European Medicines Agency; FAERS: Food and Drug Administration Adverse Event Reporting System; Mono: monotherapy; NA: not available; Poly: polytherapy; ROA: route of administration; SD: Standard Deviation; SSRI: Selective Serotonin Reuptake Inhibitors; T-mam: Transmammary; T-placent: Transplacental; * Parenteral refers to intramuscular, subcutaneous, and intravenous administrations; ° excluding Z-drugs.