Table 5.
Studies of the occurrence of ADRs related to SSRI use
| Reference | Setting | Medicines | ADRs | Sampling period | Sample size | Outcome measures |
Results (95% CI) |
Type of ADRs |
| Case-control studies | ||||||||
| Schillevoort 2002 [72] | NL | SSRIs | Extrapyramidal Syndromes (EPS) |
1985–1999 | 41cases/1,264 controls | OR | 2.2; 1.2–3.9 | A |
| Movig 2002 [73] | NL | SSRIs | Hyponatraemia | 1990–1998 | 203 cases/608 controls | OR | 3.96; 1.33 – 11.83 | A |
| Cohort study | ||||||||
| Bell 2006 [74] | US | Fluoxetine | Testosterone levels | - | 14 patients | Testosterone level | No changes | B |
| National ADR databases | ||||||||
| Trenque 2002 [75] | FR | SSRIs | Withdrawal syndrome | < 2000 | 60 cases/166,327 non cases | OR | 5.05, 3.81–6.68. | A |
| Gony 2003 76] | FR | SSRIs | Extrapyramidal Symptoms |
1995–2000 | 9 cases | OR | 2.18; 0.47–11.35 | A |
| Hedenmalm 2006 [77] | SE | SSRIs | Alopecia | < 2004 | 27 cases | IC | Sertraline = 1.63, 0.85–2.41 Citalopram = 1.22, 0.97–1.47 |
B |
| Goldstein 1997 [78] | - | Fluoxetine | First-trimester exposure on newborns | < 1996 | 796 cases | Rate % | 5.0 | C |
| Spigset 2003 [79] | SE | Nefazodone | Hepatic injury | < 2002 | 27,542 cases/ 2830764 non cases |
IC | 0.42, 0.12–0.72 | B |
| Khan 2003 [80] | US | SSRIs | Suicide | 1985–2000 | 77 cases/48,277 non cases |
Suicide rate | 0.59, 0.31 – 0.87 | A |
| Egberts 1997 [81] | NL | SSRIs | Non-puerperal lactation | 1986–1996 | 38cases/14,439 non cases | OR | 2.7; 6.4–25.4 | A |
| Kvande 2001 [82] | NO | SSRIs | Pancreatitis | < 2000 | 160 cases | No. of cases | 160 cases | B |
| Stahl 1997 [83] | SE | SSRIs | Withdrawal reactions | < 1995 | 49, 393 cases | Number of reports/106/ DDD |
Paroxetine = 1.9 Sertraline = 2.1 Fluoxetine = 0.48 |
A |
| Spigset 1999 [84] | SE | SSRIs | Not specified | 1965–1997 | 1202 cases | ADRs | Different categories reported | A + B |
| Sanz 2005 [85] | SE | SSRIs | Neonatal withdrawal syndrome | 1968–2002 | 102 cases | IC | Paroxetine = 4.07 Sertraline = 1.20 Citalopram = 1.92 Fluoxetin = 1.07 |
C |
| PEM | ||||||||
| Price 1996 [86] | UK | SSRIs | Withdrawal reactions | 1987–1992 | 50,150 patients | Reports/ 1000 prescriptions |
Paroxetine = 0.3 Sertraline = 0.03 Fluvoxamine = 0.03 Fluoxetine = 0.002 |
A |
| Layton 2001 [87] | UK | SSRIs | Abnormal bleeding | 1986–1998 | 135,754 patients | PRR | Day 1–30 = 1.38 Month 2–6 = 1.17 |
A |
| Edwards 1994 [88] | UK | Fluvoxamine | All | 1987–1988 | 10,401 patients | Incidences | A | |
| MacKay 1997 [89] | UK | SSRIs | All | 1988–1991 | 56,145 patients | Nausea, vomiting, withdrawal symptoms | ||
| Case series | ||||||||
| de Abajo 2006 [90] | - | SSRIs Venlafaxine |
Bleeding Disorders | 1988–2003 | 1,651 cases/ 10,000 controls |
PRR | 3.0, 2.1–4.4 | A |
| Gram 1999 [91] | DK | SSRIs | Bleeding Thrombocytopenia |
- | 8 cases | - | Case review | A + B |
| Case report | ||||||||
| Demers 2001 [92] | - | Fluvoxamine | Serotonin syndrome | - | 1 case | - | Case review | A |