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 3 Characteristics of studies of the occurrence of ADRs related to antibiotics 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
Czeizel 1999 [15]	HU	Erythromycin	Teratology	1980–1996	113 cases/38,151 controls	OR	1.1; 0.5–2.3	C
Seeger 2006 [16]		Fluoroquinolones	Achilles tendon rupture	1997–2001	947 cases/ 18,940 controls	OR	1.2; 0.9–1.7	B
Cohort studies
Chysky 1991[17]	DE	Ciprofloxacin	Not specified	44 days	634 patients	% ADRs	Different categories reported	A/B
Derby 1993 [18]	AU	Flucloxacillin	Cholestatic hepatitis	45 days	132,087 patients	PRR/100,000 users	7.6; 3.5–13.9	B
Jick 1994 [19]	AU	Flucloxacillin	Cholestatic hepatitis	1991–1992	77,552 patients	PRR/ 100,000 users	6.5; 2.7–15.1	B
Derby 1993b [20]	AU	Erythromycin	Cholestatic hepatitis	-	366,064 patients	PRR/100,000 users	3,6; 1.9–6.1	B
Heymann 2007 [21]	Israel	Penicillins	Pemphigus	1997–2001	150,000 patients	OR	2.03; 1.56–2.64	B
PEM
Clark 2001 [22]	UK	Fluoroquinolones	Cardiovascular events	1988–1991	36,410 patients	CRR (crude relative risk)	Atrial fibrillation: 1.0; 0.02 – 8.92	B
Inman1994 [23]	UK	Fluconazole	All	1988–1989	15,015 patients	Frequencies	Different categories reported	A
National ADR databases
Polimeni 2006 [49]	Sicilian	Antibacterials	All	1998–2002	1585 cases	ADRs	Different categories reported	A
Sachs 2006 [24]	DE	Fluoroquinolones	Anaphylaxis	1993–2004	204 cases	PRR > 2	Moxifloxacin: 2.1; Ofloxacin: 2.3 Ciprofloxacin: 2.3 Levofloxacin: 2.0	B
Fleisch 2000 [25]	CH	Levofloxacin	Tendinopathy	1986–1999	19 cases/460 non-cases	Reporting rate	Different categories reported	B
Leone 2003 [26]	IT	Fluroquinolones	Not specified	1999–2001	432 cases/ 10,011 non cases	Reporting rate	Different categories reported	A
Pierfitte 2000 [27]	FR	Sparfloxacin	Phototoxicity	1994–1996	371 cases	RtR/1000 patients	0.4	B
Frothingham 2005 [28]	US	Gatifloxacin	Glucose homeostatis abnormalities	1997–2003	453 cases/ 1427 non cases	Reporting rate/10⁷ prescriptions	477	A
Hedenmalm 1996 [29]	SE	Fluorquinolones	Sensory disturbances	1965–1993	37 cases	ADRs	Different categories reported	A
Case series
Abouesh 2002 [30]	-	Fluorquinolones Macrolides	Mania	-	102 cases	Case review	Case review	B
Smith 2005 [31]	-	Doxycycline Minocycline	ADRs	1966–2003	130 cases	Incidences	Doxycycline: 0–61% Minocycline: 11.7 – 83.3%	A
Case reports
Hällgren 2003 [32]	-	Ciprofloxacin	Steven-Johnson syndrome	1988–2000	8 cases	IC pr. 100,000 patients	0.045	B
Warner 2000 [33]	-	Clarithromycin	Acute Psychotic Stress	-	1 case	Causality assessment	Possible	A
ADRAC 1992 [34]	-	Flucloxacillin	Cholestatic hepatitis	-	1 case	Case review	Case review	B
Greco 1997 [35]	-	Clarithromycin	Glossitis, stomatitis, black tongue	-	1 case	Case review	Case review	B
Björnsson 1996 [36]	-	Doxycycline	Liver reactions	1966–1995	23 cases	Causality assessment	Likely (n = 3) Possible (n = 8)	B

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