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 4 Characteristics of studies of the occurrence of ADRs related to NSAID 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
Hernandez-Diaz 2001[37]	UK	NSAIDs	Gastrointestinal events	1993–1998	2,105 cases/ 11,500 controls	OR	1.8; 1.3 – 2.4.	A
Mockenhaupt 2003 [38]	DE/US	NSAIDs	Steven-Johnson syndrome	1989–1995	245 cases/ 1147 controls	PRR	34, 95; 11–105	B
Lacroix 2004 [39]	FR	NSAIDs	Liver injury	1998–2000	88 cases/ 178 controls	OR	Women: 6.49; 1.67–25.16 Men: 1.06; 0.36–3.12	B
Cohort studies
Lipworth 2004 [40]	DK	Ibuprofen	Mortality	1989–1995	113,538 patients	SMR (standard mortality rate)	1.21; 1.19–1.24	A/B
Ashworth 2004 [41]	CA	Diclofenac Naproxen Arthrotec	Mortality	1991–1994	18,424 patients	OR	Arthrotec: 1.4; 0.9–2.1. Diclofenac: 2.0; 1.3–3.1. Naproxen: 3.0; 1.9–4.6	A/B
Morant 2004 [42]	UK	NSAIDs	Gastrointestinal haemorrhage	1987–2001	628000 patient year	PRR	0.84; 0.60 – 1.17	A
Martin 2000 [43]	UK	Meloxicam	Gastrointestinal events	1996–1997	19,087 patients	Events/ 1000 patient-months of exposure	Dyspepsia: 28.3 Gastrointestinal haemorrhage: 0.4	A + B
National ADR databases
Lugardon 2004 [44]	FR	COX-2 inhibitors	Oeso-gastro-duodenal events:	2000–2002	505 cases/ 2,525 non-cases	OR	14.9; 9.3–23.7	A
Durrieu 2005 [45]	FR	COX-2 inhibitors	Arterial hypertension	2000–2003	34 cases	OR	3.3; 1.6–6.9.	A
Clinard 2004 [46]	FR	NSAIDs	Excess risk of adverse drug reactions	1995–1999	3983 cases/ 54,583 non- cases	OR	Different categories reported	B
Brinker 2004 [47]	US	COX-2 inhibitors	Hypertension	< 2002	34 cases	Reporting rate/10⁶person years	Rofecoxib: 5.0 Celecoxib: 1.3	A
La Grenade 2005 [48]	US	COX-2 inhibitors Meloxicam	Steven-Johnson syndrome Toxic Epidermal Necrolysis	< 2004	123 cases	Reporting rate/10⁶person years	Valdecoxib: 49 Celecoxib: 6 Rofecoxib: 3	B
Polimeni 2006 [49]	Sicilian	NSAIDs	All	1998–2002	1585 cases	PRR	Hepatitis: 14.20 Vasculitis: 7.72 Hypertension: 15.40	B
Conforti 2001 [50]	IT	NSAIDs	Gastrointestinal events	1996–1999	705 cases/ 10,608 non cases	% ADRs	Nimesulid: 10.4 Diclofenac: 21.2 Ketoprofen: 1.7 Piroxicam: 18.6	A
Ahmad 2002 [51]	US	COX-2 inhibitors	Renal failure	1969–2000	Celecoxib: 122 cases Rofecoxib: 142 cases	Case review	Case review	A
Puijenbroek 2000 [52]	NL	NSAIDs Diuretics	Drug interactions	1990–1999	305 cases/ 9517 non cases	OR	OR: 2.0, 1.1–3.7	D
Lapeyre-Mestre 2004 [53]	FR/ES	NSAIDs	Hepatic events	1982–2001	29,486 cases	OR	Different OR calculated for NSAIDs.	B
Leone 1999 [54]	IT	Nimesulide	Renal impairment	1988–1997	11cases/ 7438 non cases	Causality assessment	Possible (n = 6) Probable (n = 4) Certain (n = 1)	A
Brown 1998 [55]	UK	Tiaprofenic acid	Cystitis	1981–1996	221 cases/ 1327 non cases	ADRs/10⁵ prescriptions	1991: 4.2 1992: 5.9 1993: 4.2 1994: 34.4 1995: 18.5 1996: 6.5	B
Verrico 2003 [56]	US	COX2-inhibitors	Not specified	1999–2002	24 cases	Causality assessment	Possible (n = 29) Probable (n = 16)	A
Kahn 1997 [57]	US	NSAIDs	Necrotizing soft tissue infections	1969–1995	33 cases	Case review	N = 26	C
PEM
Layton 2004a [58]	UK	Celecoxib	Not specified	2000	17,458 patients	IDs (event incidence densitites)	Dyspepsia = 25.4 Abdominal pain = 10.6	A + B
Layton 2003b [59]	UK	Celecoxib Meloxicam	Not specified	1996–1997	34,355 patients	PRR	Different categories reported	A
Layton 2003c [60]	UK	Rofecoxib	Not specified	2000	15,268 patients	Event rate pr. 1000 patient months exposure	76 upper GI bleedings and 101 thromboembolic events	A + B
Layton 2004d [61]	UK	Rofecoxib	Exacerbation of colitis	1999	15,268 patients	IRR	5.8; 2.7–11.3	A
Kasliwal 2005 [62]	UK	COX-2 inhibitors	Gastrointestinal + thromboembolic events	1999–2000	32,726 patients	PRR	GI: 1.21; 1.09 – 1.36. Thromboembolic: 1.04; 0.50 – 2.17.	A + B
Layton 2003e [63]	UK	Rofecoxib Meloxicam	Thromboembolic events	1996–1997	34,355 patients	PRR	1.68; 1.15 – 2.46.	A
Layton 2003f [64]	UK	Rofecoxib Meloxicam	Upper GI events	1996–1997	34,355 patients	IR	0.71; 0.65 – 0.79.	A
Layton 2006g [65]	UK	COX-2 inhibitors	Serious skin reactions	1999–2000/	52,644 patients	IR/1000 patient-months	IR: 0.019	B
Layton 2003h [66]	UK	Celecoxib Meloxicam	Gastrointestinal events	1996–1997	36,545 patients	PRR	0.77; 0.69 – 0.85.	A
Case series
Onder 2004 [67]	-	NSAIDs	Psychiatric ADRs	1965–2003	27 reports with data on 453 cases	Risk factors	Age, psychiatric disorders, parturients	B
Fraunfelder 2006 [68]	-	NSAIDs	Ocular ADRs	-	569 cases	Reported ADRs	Blurred vision, conjunctivitis, visual hallucinations	B
Zimer 2007 [69]	DE	Valdecoxib	Cutaneous adverse reactions	2002–2005	5 cases	Case review	Erythematous, facial edema, dyspnea	B
Case reports
Hunter 1999 [70]	-	Bromfenac	Hepatic Failure	-	1 case	Causality assessment	Related	B
ADRAC 1998 [71]	-	Diclofenac Indomethacin Mefenamic acid	Closure of fetal ductus arterious	-	3 cases	Case review	Case review	C

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