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

Neuro-developmental disorders (as a whole)

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.
S18758
R79780
Moore (Pregabalin) (Mixed indications) (Controls exposed to LTG), 2025 Early childhood developmental concerns (any developmental concerns on any domain at the 27–30 month assessment offered to all children) during pregnancy (anytime or not specified) population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 1.31 [1.06;1.63] C
excluded (control group)
224/795   215/934 439 795
ref
S18759
R79784
Moore (Pregabalin) (Mixed indications) (Controls unexposed, general pop), 2025 Early childhood developmental concerns (any developmental concerns on any domain at the 27–30 month assessment offered to all children) during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Matched 1.32 [1.10;1.58] 224/795   1,175/7,949 1,399 795
ref
S12754
R48121
Bjørk (Controls exposed to Lamotrigine, sick) (Mixed indications), 2022 Neurodevelopmental Disorder (ND): any diagnoses of autism spectrum disorder (F84.0, F84.1, F84.5) or intellectual disability (F70, F71, F72, F73) plus F84.3, F84.4, F84.8, F84.9, F79 - Median follow up pregabalin, 5.2 (2.7-7.5) years old during pregnancy (anytime or not specified) population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No Controls: mixed indications 0.90 [0.58;1.38] C
excluded (control group)
25/1,666   133/7,950 158 1,666
ref
S12755
R48124
Bjørk (Controls unexposed NOS) (Mixed indications), 2022 Neurodevelopmental Disorder (ND): any diagnoses of autism spectrum disorder (F84.0, F84.1, F84.5) or intellectual disability (F70, F71, F72, F73) plus F84.3, F84.4, F84.8, F84.9, F79 - Median follow up pregabalin, 5.2 (2.7-7.5) years old during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) excluded Adjustment: Yes 1.05 [0.71;1.55]
excluded (control group)
25/1,666   68,295/4,463,879 68,320 1,666
ref
S12756
R48127
Bjørk (Controls unexposed, sick) (Mixed indications), 2022 Neurodevelopmental Disorder (ND): any diagnoses of autism spectrum disorder (F84.0, F84.1, F84.5) or intellectual disability (F70, F71, F72, F73) plus F84.3, F84.4, F84.8, F84.9, F79 - Median follow up pregabalin, 5.2 (2.7-7.5) years old during pregnancy (anytime or not specified) population based cohort retrospective unexposed, sick Adjustment: No Controls: epilepsy indication 0.73 [0.49;1.09] C 25/1,666   443/21,634 468 1,666
ref
S8541
R28346
Coste (Controls unexposed, NOS) (Mixed indications), 2020 Diagnosis Disorders of psychological development (F80–F89) (mean age of 3.6 years old) during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes 1.30 [0.80;2.20] 16/1,627   10,010/1,710,441 10,026 1,627
ref
Total 3 studies 1.09 [0.75;1.60] 11,893 4,088
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 Moore (Pregabalin) (Mixed indications) (Controls unexposed, general pop), 2025Moore, 2025 1 1.32[1.10; 1.58]1,39979543%ROB confusion: seriousROB selection: lowROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: low Bjørk (Controls unexposed, sick) (Mixed indications), 2022Bjørk, 2022 2 0.73[0.49; 1.09]4681,66631%ROB confusion: unclearROB selection: lowROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Coste (Controls unexposed, NOS) (Mixed indications), 2020Coste, 2020 3 1.30[0.80; 2.20]10,0261,62726%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (3 studies) I2 = 71% 1.09[0.75; 1.60]11,8934,0880.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Pregabalin) (Mixed indications) (Controls unexposed, general pop; 2: Controls unexposed, sick) (Mixed indications; 3: Controls unexposed, NOS) (Mixed indications;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.09[0.75; 1.60]11,8934,08871%NAMoore (Pregabalin) (Mixed indications) (Controls unexposed, general pop), 2025 Bjørk (Controls unexposed, sick) (Mixed indications), 2022 Coste (Controls unexposed, NOS) (Mixed indications), 2020 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.32[1.11; 1.56]11,4252,4220%NAMoore (Pregabalin) (Mixed indications) (Controls unexposed, general pop), 2025 Coste (Controls unexposed, NOS) (Mixed indications), 2020 2 unexposed, sickunexposed, sick 0.73[0.49; 1.09]4681,666 -NABjørk (Controls unexposed, sick) (Mixed indications), 2022 1 Tags Adjustment   - No  - No 0.73[0.49; 1.09]4681,666 -NABjørk (Controls unexposed, sick) (Mixed indications), 2022 1   - Yes  - Yes 1.32[1.11; 1.56]11,4252,4220%NAMoore (Pregabalin) (Mixed indications) (Controls unexposed, general pop), 2025 Coste (Controls unexposed, NOS) (Mixed indications), 2020 2 Controls   - epilepsy indication  - epilepsy indication 0.73[0.49; 1.09]4681,666 -NABjørk (Controls unexposed, sick) (Mixed indications), 2022 1 MatchedMatched 1.32[1.10; 1.58]1,399795 -NAMoore (Pregabalin) (Mixed indications) (Controls unexposed, general pop), 2025 1 All studiesAll studies 1.09[0.75; 1.60]11,8934,08871%NAMoore (Pregabalin) (Mixed indications) (Controls unexposed, general pop), 2025 Bjørk (Controls unexposed, sick) (Mixed indications), 2022 Coste (Controls unexposed, NOS) (Mixed indications), 2020 30.25.01.0

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 12754, 12755, 18758

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.27[1.09; 1.49]79,7454,0880%NAMoore (Pregabalin) (Mixed indications) (Controls unexposed, general pop), 2025 Bjørk (Controls unexposed NOS) (Mixed indications), 2022 Coste (Controls unexposed, NOS) (Mixed indications), 2020 3 unexposed, sick controlsunexposed, sick controls 0.73[0.49; 1.09]4681,666 -NABjørk (Controls unexposed, sick) (Mixed indications), 2022 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.14[0.79; 1.63]5972,46159%NAMoore (Pregabalin) (Mixed indications) (Controls exposed to LTG), 2025 Bjørk (Controls exposed to Lamotrigine, sick) (Mixed indications), 2022 20.510.01.0