Pregabalin (Epilepsy) updated on 04-22-2025

Major congenital malformations

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.
S18748
R79716
Moore (Pregabalin) (Epilepsy) (Controls exposed to LTG), 2025 Congenital conditions (any major structural congenital condition with no known associated/underlying genetic condition, as defined by EUROCAT) during pregnancy (anytime or not specified) population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 2.06 [0.67;6.35] C
excluded (control group)
4/68   16/543 20 68
ref
S18747
R79713
Moore (Pregabalin) (Epilepsy) (Controls unexposed, sick), 2025 Congenital conditions (any major structural congenital condition with no known associated/underlying genetic condition, as defined by EUROCAT) during pregnancy (anytime or not specified) excluded population based cohort retrospective unexposed, sick Adjustment: No Matched 5.13 [1.49;17.70]
excluded (exposition period)
4/68   8/667 12 68
ref
S18715
R79623
The NAAED (Pregabalin) (Epilepsy), 2025 Major congenital malformations 1st trimester prospective cohort exposed to other treatment, sick Adjustment: No 5.22 [0.28;98.62] C 0/5   40/1,944 40 5
ref
S16713
R70303
Battino, 2024 Major congenital malformations (MCMs) early pregnancy prospective cohort exposed to other treatment, sick Adjustment: No 2.42 [0.14;43.19] C 0/7   110/3,584 110 7
ref
S7796
R23014
Vajda (Pregabalin) (Controls exposed to Lamotrigine, sick), 2019 Fetal malformations at least 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 18.80 [0.36;971.86] C
excluded (control group)
0/1   20/406 20 1
ref
S7797
R23015
Vajda (Pregabalin) (Controls unexposed, sick), 2019 Fetal malformations at least 1st trimester prospective cohort unexposed, sick Adjustment: No 31.00 [0.56;1711.11] C 0/1   5/176 5 1
ref
Total 3 studies 5.55 [0.89;34.62] 155 13
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 The NAAED (Pregabalin) (Epilepsy), 2025The NAAED, 2025 1 5.22[0.28; 98.62]40539%ROB confusion: criticalROB selection: unclearROB classification: moderateROB missing: unclearROB mesure: criticalROB reporting: low Battino, 2024Battino, 2024 2.42[0.14; 43.19]110740%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Vajda (Pregabalin) (Controls unexposed, sick), 2019Vajda, 2019 2 31.00[0.56; 1711.11]5121%ROB confusion: criticalROB selection: moderateROB classification: lowROB missing: moderateROB mesure: moderateROB reporting: moderate Total (3 studies) I2 = 0% 5.55[0.89; 34.62]155130.9100.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Pregabalin) (Epilepsy; 2: Pregabalin) (Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 5.55[0.89; 34.62]155130%NAThe NAAED (Pregabalin) (Epilepsy), 2025 Battino, 2024 Vajda (Pregabalin) (Controls unexposed, sick), 2019 3 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 31.00[0.56; 1711.11]51 -NAVajda (Pregabalin) (Controls unexposed, sick), 2019 1 exposed to other treatment, sickexposed to other treatment, sick 3.53[0.45; 27.61]150120%NAThe NAAED (Pregabalin) (Epilepsy), 2025 Battino, 2024 2 Tags Adjustment   - No  - No 5.55[0.89; 34.62]155130%NAThe NAAED (Pregabalin) (Epilepsy), 2025 Battino, 2024 Vajda (Pregabalin) (Controls unexposed, sick), 2019 3 All studiesAll studies 5.55[0.89; 34.62]155130%NAThe NAAED (Pregabalin) (Epilepsy), 2025 Battino, 2024 Vajda (Pregabalin) (Controls unexposed, sick), 2019 30.5100.01.0

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 7796, 18748

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed, sick controlsunexposed, sick controls Out of scale31.00[0.56; 1711.11]51 -NAVajda (Pregabalin) (Controls unexposed, sick), 2019 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 5.05[0.81; 31.28]170130%NAThe NAAED (Pregabalin) (Epilepsy), 2025 Battino, 2024 Vajda (Pregabalin) (Controls exposed to Lamotrigine, sick), 2019 30.510.01.0