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

Microcephaly / Small head circumference for gestational age

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.
S16016
R66488		 Christensen (Lamotrigine) (All indications), 2024 Microcephaly (z-score for head circumference ≤3rd percentile for gestational week, sex, and country (including newborns with congenital malformations)) during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 0.94 [0.83;1.07] 274/8,756   134,023/4,467,848 134,297 8,756
ref
S10035
R36149		 Blotière (Lamotrigine) (Mixed indications), 2019 Microcephaly (until 24 months of age, identifiable by: Q02; brain MRI; according to the EUROCAT definition) 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.43 [0.20;10.17] C 1/2,997   438/1,875,733 439 2,997
ref
Total 2 studies 0.94 [0.83;1.07] 134,736 11,753
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 Christensen (Lamotrigine) (All indications), 2024Christensen, 2024 1 0.94[0.83; 1.07]134,2978,756100%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: unclearROB reporting: moderate Blotière (Lamotrigine) (Mixed indications), 2019Blotière, 2019 2 1.43[0.20; 10.17]4392,9970%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (2 studies) I2 = 0% 0.94[0.83; 1.07]134,73611,7530.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Lamotrigine) (All indications; 2: Lamotrigine) (Mixed indications;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.94[0.83; 1.07]134,73611,7530%NAChristensen (Lamotrigine) (All indications), 2024 Blotière (Lamotrigine) (Mixed indications), 2019 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.94[0.83; 1.07]134,73611,7530%NAChristensen (Lamotrigine) (All indications), 2024 Blotière (Lamotrigine) (Mixed indications), 2019 2 Tags Adjustment   - No  - No 1.43[0.20; 10.17]4392,997 -NABlotière (Lamotrigine) (Mixed indications), 2019 1   - Yes  - Yes 0.94[0.83; 1.07]134,2978,756 -NAChristensen (Lamotrigine) (All indications), 2024 1 All studiesAll studies 0.94[0.83; 1.07]134,73611,7530%NAChristensen (Lamotrigine) (All indications), 2024 Blotière (Lamotrigine) (Mixed indications), 2019 20.25.01.0

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) 0.94[0.83; 1.07]134,73611,7530%NAChristensen (Lamotrigine) (All indications), 2024 Blotière (Lamotrigine) (Mixed indications), 2019 20.510.01.0