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

Low birth weight (< 2500g)

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.
S18701
R79553		 Mazzone (Lamotrigine) (Mixed indications), 2025 Low birth weight during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 0.95 [0.71;1.27] 104/1,469   30,896/624,794 31,000 1,469
ref
S16016
R66486		 Christensen (Lamotrigine) (All indications), 2024 Low birth weight (<2500 g) during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 0.94 [0.84;1.05] 395/8,756   141,442/4,467,848 141,837 8,756
ref
S8978
R30432		 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Weight at birth <2500 g during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.15 [0.99;1.35] C 172/2,813   91,172/1,707,707 91,344 2,813
ref
S8974
R30418		 Hernández-Díaz (Lamotrigine) (Mixed indications), 2014 Low birth weight (< 2500g) throughout pregnancy prospective cohort unexposed, disease free Adjustment: No 1.20 [0.71;2.03] C 74/1,581   18/457 92 1,581
ref
S8953
R30312		 Veiby (Lamotrigine) (Controls unexposed, disease free) b, 2013 Low birth weight (< 2500 grams) during pregnancy (anytime or not specified) prospective cohort unexposed, disease free excluded Adjustment: Yes 1.20 [0.50;2.80]
excluded (control group) 		6/103   5,024/106,899 5,030 103
ref
S8954
R30326		 Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 Low birth weight (< 2500 grams) during pregnancy (anytime or not specified) prospective cohort unexposed, sick Adjustment: No 1.43 [0.55;3.75] C 6/103   16/386 22 103
ref
Total 5 studies 1.03 [0.91;1.16] 264,295 14,722
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 Mazzone (Lamotrigine) (Mixed indications), 2025Mazzone, 2025 1 0.95[0.71; 1.27]31,0001,46914%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Christensen (Lamotrigine) (All indications), 2024Christensen, 2024 2 0.94[0.84; 1.05]141,8378,75646%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020Coste, 2020 3 1.15[0.99; 1.35]91,3442,81334%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: moderateROB mesure: moderateROB reporting: moderate Hernández-Díaz (Lamotrigine) (Mixed indications), 2014Hernández-Díaz, 2014 4 1.20[0.71; 2.03]921,5815%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013Veiby, 2013 5 1.43[0.55; 3.75]221032%ROB confusion: seriousROB selection: lowROB classification: lowROB missing: moderateROB mesure: moderateROB reporting: moderate Total (5 studies) I2 = 28% 1.03[0.91; 1.16]264,29514,7220.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Lamotrigine) (Mixed indications; 2: Lamotrigine) (All indications; 3: Lamotrigine) (Controls unexposed NOS) (Mixed indications; 4: Lamotrigine) (Mixed indications; 5: Lamotrigine) (Controls unexposed, sick) ;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.03[0.91; 1.16]264,29514,72228%NAMazzone (Lamotrigine) (Mixed indications), 2025 Christensen (Lamotrigine) (All indications), 2024 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Hernández-Díaz (Lamotrigine) (Mixed indications), 2014 Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 5 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.02[0.90; 1.17]264,27314,61941%NAMazzone (Lamotrigine) (Mixed indications), 2025 Christensen (Lamotrigine) (All indications), 2024 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Hernández-Díaz (Lamotrigine) (Mixed indications), 2014 4 unexposed, sickunexposed, sick 1.43[0.55; 3.75]22103 -NAVeiby (Lamotrigine) (Controls unexposed, sick) b, 2013 1 Tags Adjustment   - No  - No 1.16[1.01; 1.35]91,4584,4970%NACoste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Hernández-Díaz (Lamotrigine) (Mixed indications), 2014 Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 3   - Yes  - Yes 0.94[0.85; 1.04]172,83710,2250%NAMazzone (Lamotrigine) (Mixed indications), 2025 Christensen (Lamotrigine) (All indications), 2024 2 All studiesAll studies 1.03[0.91; 1.16]264,29514,72228%NAMazzone (Lamotrigine) (Mixed indications), 2025 Christensen (Lamotrigine) (All indications), 2024 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Hernández-Díaz (Lamotrigine) (Mixed indications), 2014 Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 50.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-1.21.20.5910.000Mazzone (Lamotrigine) (Mixed indications), 2025Christensen (Lamotrigine) (All indications), 2024Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020Hernández-Díaz (Lamotrigine) (Mixed indications), 2014Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013

Asymetry test p-value = 0.4459 (by Egger's regression)

slope=-0.0572 (0.0938); intercept=0.8483 (0.9692); t=0.8753; p=0.4459

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 8953

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.02[0.91; 1.15]269,30314,72223%NAMazzone (Lamotrigine) (Mixed indications), 2025 Christensen (Lamotrigine) (All indications), 2024 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Hernández-Díaz (Lamotrigine) (Mixed indications), 2014 Veiby (Lamotrigine) (Controls unexposed, disease free) b, 2013 5 unexposed, sick controlsunexposed, sick controls 1.43[0.55; 3.75]22103 -NAVeiby (Lamotrigine) (Controls unexposed, sick) b, 2013 10.510.01.0