Gabapentin (All indications) 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.
S18752
R79755		 Moore (Gabapentin) (Mixed indications) (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 0.78 [0.51;1.21] C
excluded (control group) 		44/2,103   39/1,470 83 2,103
ref
S18753
R79759		 Moore (Gabapentin) (Mixed indications) (Controls unexposed, general pop), 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 (general population or NOS) Adjustment: Yes Matched 0.93 [0.67;1.29]
excluded (exposition period) 		44/2,103   400/20,608 444 2,103
ref
S16190
R67083		 The NAAED (Controls exposed to LTG) (Indications NOS), 2025 Major congenital malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 0.67 [0.24;1.86] C
excluded (control group) 		4/296   52/2,587 56 296
ref
S16180
R67072		 The NAAED (Controls unexposed, disease free) (Indications NOS), 2025 Major congenital malformations 1st trimester prospective cohort unexposed, disease free Adjustment: No 1.22 [0.40;3.69] C 4/296   15/1,346 19 296
ref
S16582
R69645		 Battino (Gabapentin) (Epilepsy), 2024 Major congenital malformations (MCMs) early pregnancy prospective cohort exposed to other treatment, sick Adjustment: No 0.88 [0.12;6.46] C 1/37   110/3,584 111 37
ref
S8485
R27851		 Arkilo, 2015 Major malformations during pregnancy (anytime or not specified) excluded retrospective cohort exposed to other treatment, sick Adjustment: No 47.00 [0.38;5814.69] C
excluded (exposition period) 		0/1   0/24 0 1
ref
S8507
R27984		 Källén (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013 Relatively severe malformations early pregnancy population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 0.48 [0.12;2.03] C
excluded (control group) 		2/119   37/1,084 39 119
ref
S8508
R27986		 Källén (Controls unexposed, NOS) (Indications NOS), 2013 Relatively severe malformations early pregnancy population based cohort retrospective unexposed (general population or NOS) Adjustment: No 0.53 [0.13;2.13] C 2/119   49,499/1,575,847 49,501 119
ref
S8496
R27909		 Vajda (Controls exposed to Lamotrigine, sick), 2013 Fetal malformations at least 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 0.83 [0.05;14.66] C
excluded (control group) 		0/14   13/315 13 14
ref
S8497
R27910		 Vajda (Controls unexposed, sick), 2013 Fetal malformations at least 1st trimester prospective cohort unexposed, sick Adjustment: No 0.95 [0.05;18.18] C 0/14   5/147 5 14
ref
S8487
R27874		 Mawer (Controls exposed to Lamotrigine, sick), 2010 Major malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 4.60 [0.15;144.69] C
excluded (control group) 		0/2   2/37 2 2
ref
S8488
R27876		 Mawer (Controls unexposed, disease free), 2010 Major malformations 1st trimester prospective cohort unexposed, disease free excluded Adjustment: No Matched 14.28 [0.53;384.83] C
excluded (control group) 		0/2   6/285 6 2
ref
S8489
R27878		 Mawer (Controls unexposed, sick), 2010 Major malformations 1st trimester prospective cohort unexposed, sick Adjustment: No 8.78 [0.24;318.70] C 0/2   1/41 1 2
ref
S8493
R27897		 Morrow (Controls exposed to Lamotrigine, sick), 2006 Major congenital malformation 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 0.99 [0.13;7.64] C
excluded (control group) 		1/31   21/647 22 31
ref
S8494
R27905		 Morrow (Controls unexposed, sick), 2006 Major congenital malformation 1st trimester prospective cohort unexposed, sick Adjustment: No 0.91 [0.11;7.55] C 1/31   8/227 9 31
ref
S8486
R27858		 Dean, 2002 Major congenital malformations at least 1st trimester retrospective cohort unexposed, sick Adjustment: No 14.20 [0.23;878.06] C 0/1   2/38 2 1
ref
Total 7 studies 1.05 [0.52;2.11] 49,648 500
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 (Controls unexposed, disease free) (Indications NOS), 2025The NAAED, 2025 1 1.22[0.40; 3.69]1929640%ROB confusion: seriousROB selection: unclearROB classification: moderateROB missing: unclearROB mesure: criticalROB reporting: low Battino (Gabapentin) (Epilepsy), 2024Battino, 2024 2 0.88[0.12; 6.46]1113712%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Källén (Controls unexposed, NOS) (Indications NOS), 2013Källén, 2013 3 0.53[0.13; 2.13]49,50111925%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Vajda (Controls unexposed, sick), 2013Vajda, 2013 4 0.95[0.05; 18.18]5146%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Mawer (Controls unexposed, sick), 2010Mawer, 2010 5 8.78[0.24; 318.70]124%ROB confusion: criticalROB selection: moderateROB classification: lowROB missing: moderateROB mesure: moderateROB reporting: moderate Morrow (Controls unexposed, sick), 2006Morrow, 2006 6 0.91[0.11; 7.55]93111%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Dean, 2002Dean, 2002 14.20[0.23; 878.06]213%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (7 studies) I2 = 0% 1.05[0.52; 2.11]49,6485000.250.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, disease free) (Indications NOS; 2: Gabapentin) (Epilepsy; 3: Controls unexposed, NOS) (Indications NOS; 4: Controls unexposed, sick; 5: Controls unexposed, sick; 6: Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.05[0.52; 2.11]49,6485000%NAThe NAAED (Controls unexposed, disease free) (Indications NOS), 2025 Battino (Gabapentin) (Epilepsy), 2024 Källén (Controls unexposed, NOS) (Indications NOS), 2013 Vajda (Controls unexposed, sick), 2013 Mawer (Controls unexposed, sick), 2010 Morrow (Controls unexposed, sick), 2006 Dean, 2002 7 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.88[0.37; 2.10]49,5204150%NAThe NAAED (Controls unexposed, disease free) (Indications NOS), 2025 Källén (Controls unexposed, NOS) (Indications NOS), 2013 2 unexposed, sickunexposed, sick 1.87[0.44; 7.99]17480%NAVajda (Controls unexposed, sick), 2013 Mawer (Controls unexposed, sick), 2010 Morrow (Controls unexposed, sick), 2006 Dean, 2002 4 exposed to other treatment, sickexposed to other treatment, sick 0.88[0.12; 6.46]11137 -NABattino (Gabapentin) (Epilepsy), 2024 1 Tags Adjustment   - No  - No 1.05[0.52; 2.11]49,6485000%NAThe NAAED (Controls unexposed, disease free) (Indications NOS), 2025 Battino (Gabapentin) (Epilepsy), 2024 Källén (Controls unexposed, NOS) (Indications NOS), 2013 Vajda (Controls unexposed, sick), 2013 Mawer (Controls unexposed, sick), 2010 Morrow (Controls unexposed, sick), 2006 Dean, 2002 7 All studiesAll studies 1.05[0.52; 2.11]49,6485000%NAThe NAAED (Controls unexposed, disease free) (Indications NOS), 2025 Battino (Gabapentin) (Epilepsy), 2024 Källén (Controls unexposed, NOS) (Indications NOS), 2013 Vajda (Controls unexposed, sick), 2013 Mawer (Controls unexposed, sick), 2010 Morrow (Controls unexposed, sick), 2006 Dean, 2002 70.250.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-4.95.02.5250.000The NAAED (Controls unexposed, disease free) (Indications NOS), 2025Battino (Gabapentin) (Epilepsy), 2024Källén (Controls unexposed, NOS) (Indications NOS), 2013Vajda (Controls unexposed, sick), 2013Mawer (Controls unexposed, sick), 2010Morrow (Controls unexposed, sick), 2006Dean, 2002

Asymetry test p-value = 0.1415 (by Egger's regression)

slope=-0.9127 (0.6037); intercept=1.1170 (0.6402); t=1.7447; p=0.1415

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 8493, 8487, 8488, 8507, 8496, 18752, 16190

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.17[0.34; 3.99]49,52641741%NAThe NAAED (Controls unexposed, disease free) (Indications NOS), 2025 Källén (Controls unexposed, NOS) (Indications NOS), 2013 Mawer (Controls unexposed, disease free), 2010 3 unexposed, sick controlsunexposed, sick controls 1.87[0.44; 7.99]17480%NAVajda (Controls unexposed, sick), 2013 Mawer (Controls unexposed, sick), 2010 Morrow (Controls unexposed, sick), 2006 Dean, 2002 4 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.73[0.37; 1.45]2434990%NAThe NAAED (Controls exposed to LTG) (Indications NOS), 2025 Battino (Gabapentin) (Epilepsy), 2024 Källén (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013 Vajda (Controls exposed to Lamotrigine, sick), 2013 Mawer (Controls exposed to Lamotrigine, sick), 2010 Morrow (Controls exposed to Lamotrigine, sick), 2006 60.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Bromley (Gabapentine) (All indications) (All ...Bromley (Gabapentine) (All indications) (All Major Malformations (Cohort studies)) 1.78[0.50; 6.29]89%-U,GPunexposed (general population or NOS)Anyduring pregnancy (anytime or not specified)studies TTT2 Bromley (Gabapentine) (All indications) (All ...Bromley (Gabapentine) (All indications) (All Major Malformations (Cohort studies)) 1.77[0.46; 6.90]0%-U,Sunexposed, sickAnyduring pregnancy (anytime or not specified)studies TTT3 Bromley (Gabapentine) (All indications) (All ...Bromley (Gabapentine) (All indications) (All Major Malformations (Cohort studies)) 0.92[0.34; 2.47]58%-Eexposed to other treatment, sickAnyduring pregnancy (anytime or not specified)studies TTT4 Bromley (Gabapentine) (All indications) (All ...Bromley (Gabapentine) (All indications) (All Major Malformations (Database studies)) 0.53[0.03; 9.48]21NA-Eexposed to other treatment, sickAnyduring pregnancy (anytime or not specified)studies TTT1 Desrochers (Gabapentin) (Major congenital mal ...Desrochers (Gabapentin) (Major congenital malformations) 1.44[1.28; 1.61]0%-Wwhatever (meta-analysis)Anyduring pregnancy (anytime or not specified)studies TTT8 Veroniki a (NMA) (All indications) (Overall m ...Veroniki a (NMA) (All indications) (Overall major congenital malformations) 1.00[0.47; 1.89]NA-Wwhatever (meta-analysis)Anyduring pregnancy (anytime or not specified)studies TTT-9 metaPregmetaPreg 1.05[0.52; 2.11]0%500----The NAAED (Controls unexposed, disease free) (Indications NOS), 2025 Battino (Gabapentin) (Epilepsy), 2024 Källén (Controls unexposed, NOS) (Indications NOS), 2013 Vajda (Controls unexposed, sick), 2013 Mawer (Controls unexposed, sick), 2010 Morrow (Controls unexposed, sick), 2006 Dean, 2002 70.510.01.0