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

Severe cognitive developmental delay (Mental retardation) (3-6 years old)

id	Study   Auto Madley-Dowd_UK (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024Bjørk (Controls exposed to Lamotrigine, sick) (Mixed indications), 2022Bjørk (Controls unexposed NOS) (Mixed indications), 2022Bjørk (Controls unexposed, sick) (Mixed indications), 2022Coste (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020Coste (Controls unexposed, NOS) (Mixed indications), 2020	Lib. in paper	Exposition period  Auto during pregnancy (anytime or not specified)1st trimester2nd trimester3rd trimester2nd and/or 3rd trimesterthroughout pregnancyearly pregnancydays before deliverylate pregnancypreconception-onlypericonceptionalpreconceptional for kinetic reasonat least 1st trimester3 months (or more) before pregnancy or during pregnancy1st and 2nd trimester3 months or more before pregnancy or1st trimester	Study type  All studies Case control excluded Only case control	Control type    Auto unexposed (general population or NOS)unexposed, sickunexposed, disease freeexposed to other treatment, sicknot specifiedsiblingwhatever (meta-analysis)	Tags	OR 95%CI	x1/n1 x0/n0	no cases	no exposed	ROB	Ref.
S17269 R72292	Madley-Dowd_UK (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024	Intellectual disability - ICD10 codes - Mean 5 years old	during pregnancy (anytime or not specified)	retrospective cohort (claims database)	unexposed (general population or NOS)	Adjustment: No	0.56 [0.04;9.01] C	0/408   1,119/514,066	1,119	408		ref
S12754 R48120	Bjørk (Controls exposed to Lamotrigine, sick) (Mixed indications), 2022	Diagnosis of intellectual disability (ID): mild ID (F70), moderate ID (F71), severe ID (F72), and profound ID (F73) - 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	0.88 [0.34;2.30] C excluded (control group)	5/1,666   27/7,950	32	1,666		ref
S12755 R48123	Bjørk (Controls unexposed NOS) (Mixed indications), 2022	Diagnosis of intellectual disability (ID): mild ID (F70), moderate ID (F71), severe ID (F72), and profound ID (F73) - 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	1.01 [0.42;2.43] excluded (control group)	5/1,666   16,384/4,463,879	16,389	1,666		ref
S12756 R48126	Bjørk (Controls unexposed, sick) (Mixed indications), 2022	Diagnosis of intellectual disability (ID): mild ID (F70), moderate ID (F71), severe ID (F72), and profound ID (F73) - 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	0.47 [0.19;1.14] C	5/1,666   139/21,634	144	1,666		ref
S10100 R36799	Coste (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020	Diagnosis Mental retardation (F70–F79) (mean age of 3.7 years old)	during pregnancy (anytime or not specified)	retrospective cohort (claims database)	exposed to other treatment, sick excluded	Adjustment: Yes	0.60 [0.20;1.80] excluded (control group)	7/1,627   15/2,916	22	1,627		ref
S8541 R28345	Coste (Controls unexposed, NOS) (Mixed indications), 2020	Diagnosis Mental retardation (F70–F79) (mean age of 3.6 years old)	during pregnancy (anytime or not specified)	retrospective cohort (claims database)	unexposed (general population or NOS)	Adjustment: Yes	1.70 [0.80;3.60]	7/1,627   3,398/1,710,441	3,405	1,627		ref
					Total	3 studies	0.87 [0.31;2.44]		4,668	3,701
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

Sensitivity analysis

Publication bias and p-hacking diagnosis

Sub-groups analysis using all included studies

excluded 10100, 12754, 12755