Fluvoxamine updated on 07-01-2025

All congenital malformations (majors, minors, majors and minors, or unspecified)

R analysis
id Study   Lib. in paper Exposition period    Study type 
 Control type 
 
Tags OR 95%CI x1/n1 x0/n0 no cases no exposed ROB Ref.
S7440
R23478		 Bérard, 2017 Major congenital malformations overall 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) 0.63 [0.23;1.77] -/55   -/14,847 - 55
ref
S6735
R23480		 Furu, 2015 Major birth defects 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 0.77 [0.38;1.56] 9/255   71,374/2,266,875 71,383 255
ref
S5963
R23479		 Einarson, 2009 Major malformations 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 1.44 [0.33;6.27] C 2/52   25/928 27 52
ref
S6427
R23481		 Oberlander, 2008 Major congenital anomalies 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.53 [0.13;2.13] C 2/119   3,369/107,320 3,371 119
ref
S6770
R19124		 Källén, 2007 Any congenital malformation (irrespective of severity) early pregnancy population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.05 [0.13;3.80] 2/38   41,233/873,876 41,235 38
ref
Total 5 studies 0.77 [0.48;1.25] 116,016 519
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

StudyTE95% CIn casesn exposedweightROBABCDEF Bérard, 2017Bérard, 2017 0.63[0.23; 1.77]-5522%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Furu, 2015Furu, 2015 0.77[0.38; 1.56]71,38325547%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Einarson, 2009Einarson, 2009 1.44[0.33; 6.27]275211%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: unclearROB mesure: criticalROB reporting: moderate Oberlander, 2008Oberlander, 2008 0.53[0.13; 2.13]3,37111912%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: unclearROB mesure: criticalROB reporting: moderate Källén, 2007Källén, 2007 1.05[0.13; 3.80]41,235388%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: lowROB mesure: unclearROB reporting: moderate Total (5 studies) I2 = 0% 0.77[0.48; 1.25]116,0165190.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.77[0.48; 1.25]116,0165190%NABérard, 2017 Furu, 2015 Einarson, 2009 Oberlander, 2008 Källén, 2007 5 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.82[0.47; 1.42]116,0164640%NAFuru, 2015 Einarson, 2009 Oberlander, 2008 Källén, 2007 4 unexposed, sickunexposed, sick 0.63[0.23; 1.75]-55 -NABérard, 2017 1 Tags Adjustment   - No  - No 0.85[0.31; 2.34]3,3981710%NAEinarson, 2009 Oberlander, 2008 2   - Yes  - Yes 0.75[0.43; 1.30]112,6183480%NABérard, 2017 Furu, 2015 Källén, 2007 3 Monotherapy   - no or not specified  - no or not specified 1.44[0.33; 6.27]2752 -NAEinarson, 2009 1   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 0.72[0.40; 1.29]71,3833100%NABérard, 2017 Furu, 2015 2   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.70[0.24; 2.05]44,6061570%NAOberlander, 2008 Källén, 2007 2 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 0.63[0.23; 1.75]-55 -NABérard, 2017 1 All studiesAll studies 0.77[0.48; 1.25]116,0165190%NABérard, 2017 Furu, 2015 Einarson, 2009 Oberlander, 2008 Källén, 2007 50.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-2.01.81.0330.000Bérard, 2017Furu, 2015Einarson, 2009Oberlander, 2008Källén, 2007

Asymetry test p-value = 0.6061 (by Egger's regression)

slope=-0.5137 (0.4705); intercept=0.4907 (0.8546); t=0.5742; p=0.6061

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 0.82[0.47; 1.42]116,0164640%NAFuru, 2015 Einarson, 2009 Oberlander, 2008 Källén, 2007 4 unexposed, sick controlsunexposed, sick controls 0.63[0.23; 1.75]-55 -NABérard, 2017 10.510.01.0