Lamotrigine (All indications) updated on 04-22-2025

Hypospadias

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.
S19314
R81801
Kim (Lamotrigine) (Indications NOS), 2026 Hypospadias 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 3.30 [0.30;36.26] 1/718   2,427/2,489,078 2,428 718
ref
S15197
R62332
Cohen (Lamotrigine) (Mixed indications), 2023 Hypospadias 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Partial overlapping 1.01 [0.66;1.55] -/8,339   -/4,866,362 - 8,339
ref
S10035
R36163
Blotière (Lamotrigine) (Mixed indications), 2019 Hypospadias 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes 1.20 [0.60;2.60] 7/2,997   3,371/1,875,733 3,378 2,997
ref
S8964
R30359
Veiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014 Hypospadias throughout pregnancy population based cohort retrospective unexposed, disease free Adjustment: No Partial overlapping 2.41 [0.90;6.44] C 4/833   1,543/771,412 1,547 833
ref
S8908
R30105
Källén (Lamotrigine) (Indications NOS), 2013 Hypospadias early pregnancy population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Partial overlapping 0.87 [0.18;2.04] 3/1,084   4,552/1,575,847 4,555 1,084
ref
Total 5 studies 1.17 [0.84;1.62] 11,908 13,971
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 Kim (Lamotrigine) (Indications NOS), 2026Kim, 2026 1 3.30[0.30; 36.26]2,4287182%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Cohen (Lamotrigine) (Mixed indications), 2023Cohen, 2023 2 1.01[0.66; 1.55]-8,33959%ROB confusion: seriousROB selection: lowROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Blotière (Lamotrigine) (Mixed indications), 2019Blotière, 2019 3 1.20[0.60; 2.60]3,3782,99720%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Veiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014Veiby, 2014 4 2.41[0.90; 6.44]1,54783311%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Källén (Lamotrigine) (Indications NOS), 2013Källén, 2013 5 0.87[0.18; 2.04]4,5551,0847%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Total (5 studies) I2 = 0% 1.17[0.84; 1.62]11,90813,9710.210.01.0ROB: A: confounding, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Lamotrigine) (Indications NOS; 2: Lamotrigine) (Mixed indications; 3: Lamotrigine) (Mixed indications; 4: Lamotrigine) (Controls unexposed, disease free) (Mixed indications; 5: Lamotrigine) (Indications NOS;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.17[0.84; 1.62]11,90813,9710%NAKim (Lamotrigine) (Indications NOS), 2026 Cohen (Lamotrigine) (Mixed indications), 2023 Blotière (Lamotrigine) (Mixed indications), 2019 Veiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014 Källén (Lamotrigine) (Indications NOS), 2013 5 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.17[0.84; 1.62]11,90813,9710%NAKim (Lamotrigine) (Indications NOS), 2026 Cohen (Lamotrigine) (Mixed indications), 2023 Blotière (Lamotrigine) (Mixed indications), 2019 Veiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014 Källén (Lamotrigine) (Indications NOS), 2013 5 Tags Adjustment   - No  - No 2.41[0.90; 6.44]1,547833 -NAVeiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014 1   - Yes  - Yes 1.06[0.75; 1.51]10,36113,1380%NAKim (Lamotrigine) (Indications NOS), 2026 Cohen (Lamotrigine) (Mixed indications), 2023 Blotière (Lamotrigine) (Mixed indications), 2019 Källén (Lamotrigine) (Indications NOS), 2013 4 Partial overlappingPartial overlapping 1.20[0.71; 2.01]6,10210,25626%NACohen (Lamotrigine) (Mixed indications), 2023 Veiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014 Källén (Lamotrigine) (Indications NOS), 2013 3 All studiesAll studies 1.17[0.84; 1.62]11,90813,9710%NAKim (Lamotrigine) (Indications NOS), 2026 Cohen (Lamotrigine) (Mixed indications), 2023 Blotière (Lamotrigine) (Mixed indications), 2019 Veiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014 Källén (Lamotrigine) (Indications NOS), 2013 50.210.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-2.93.01.4680.000Kim (Lamotrigine) (Indications NOS), 2026Cohen (Lamotrigine) (Mixed indications), 2023Blotière (Lamotrigine) (Mixed indications), 2019Veiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014Källén (Lamotrigine) (Indications NOS), 2013

Asymetry test p-value = 0.2619 (by Egger's regression)

slope=-0.2038 (0.2951); intercept=1.0834 (0.7860); t=1.3784; p=0.2619

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) 1.17[0.84; 1.62]11,90813,9710%NAKim (Lamotrigine) (Indications NOS), 2026 Cohen (Lamotrigine) (Mixed indications), 2023 Blotière (Lamotrigine) (Mixed indications), 2019 Veiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014 Källén (Lamotrigine) (Indications NOS), 2013 50.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Veroniki a (NMA) (Hypospadias)Veroniki a (NMA) (Hypospadias) 0.66[0.23; 2.26]-Wwhatever (meta-analysis)Anyduring pregnancy (anytime or not specified)studies TTT8 metaPregmetaPreg 1.17[0.84; 1.62]0%13,971----Kim (Lamotrigine) (Indications NOS), 2026 Cohen (Lamotrigine) (Mixed indications), 2023 Blotière (Lamotrigine) (Mixed indications), 2019 Veiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014 Källén (Lamotrigine) (Indications NOS), 2013 50.510.01.0