Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, SSRIs and NSAIDs

Aagaard, Lise; Hansen, Ebba Holme

doi:10.1186/1472-6904-9-4

Table 5 Studies of the occurrence of ADRs related to SSRI use

From: Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, SSRIs and NSAIDs

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

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