Fluvoxamine updated on 07-01-2025

Congenital heart defects

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
R21965		 Bérard, 2017 Circulatory system 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) 2.00 [0.62;6.47] -/55   -/14,847 - 55
ref
S6247
R16574		 Malm, 2011 All major cardiovascular anomalies 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 0.56 [0.14;2.25] 2/240   8,137/628,607 8,139 240
ref
S6427
R17647		 Oberlander, 2008 Cardiovascular congenital defects 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.88 [0.05;14.16] C 0/119   512/107,320 512 119
ref
Total 3 studies 1.15 [0.49;2.69] 8,651 414
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 2.00[0.62; 6.47]-5553%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Malm, 2011Malm, 2011 0.56[0.14; 2.25]8,13924038%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Oberlander, 2008Oberlander, 2008 0.88[0.05; 14.16]5121199%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: unclearROB mesure: criticalROB reporting: moderate Total (3 studies) I2 = 0% 1.15[0.49; 2.69]8,6514140.25.01.0ROB: 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 1.15[0.49; 2.69]8,6514140%NABérard, 2017 Malm, 2011 Oberlander, 2008 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.61[0.18; 2.12]8,6513590%NAMalm, 2011 Oberlander, 2008 2 unexposed, sickunexposed, sick 2.00[0.62; 6.46]-55 -NABérard, 2017 1 Tags Adjustment   - No  - No 0.88[0.05; 14.16]512119 -NAOberlander, 2008 1   - Yes  - Yes 1.12[0.32; 3.88]8,13929547%NABérard, 2017 Malm, 2011 2 Monotherapy   - no or not specified  - no or not specified 0.56[0.14; 2.24]8,139240 -NAMalm, 2011 1   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 2.00[0.62; 6.46]-55 -NABérard, 2017 1   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.88[0.05; 14.16]512119 -NAOberlander, 2008 1 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 2.00[0.62; 6.46]-55 -NABérard, 2017 1 All studiesAll studies 1.15[0.49; 2.69]8,6514140%NABérard, 2017 Malm, 2011 Oberlander, 2008 30.25.01.0

Publication bias and p-hacking diagnosis

funnel plot

Funnel plot not drawn. Less than 3 points.

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

not enought points

p values plot

Funnel plot not drawn. Less than 3 points.

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) 0.61[0.18; 2.12]8,6513590%NAMalm, 2011 Oberlander, 2008 2 unexposed, sick controlsunexposed, sick controls 2.00[0.62; 6.46]-55 -NABérard, 2017 10.510.01.0