Pregabalin (All indications) - Medication and Pregnancy KB

Pregabalin (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 All studies Case control excluded Only case control	Control type	Tags	OR 95%CI	x1/n1 x0/n0	no cases	no exposed	ROB	Ref.
S19324 R81908	Kim (Controls exposed to LTG) (Pregabalin) (Indications NOS), 2026	Microcephaly	1st trimester	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: No	0.53 [0.06;5.13] ^C excluded (control group)	1/449 3/718	4	449		ref
S19317 R81836	Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026	Microcephaly	1st trimester	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: Yes	1.77 [0.25;12.67]	1/449 2,473/2,489,078	2,474	449		ref
S16068 R66683	Christensen (All indications) (Controls exposed to LTG), 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	exposed to other treatment, sick excluded	Adjustment: No	1.21 [0.94;1.55] ^C excluded (control group)	83/2,214 274/8,756	357	2,214		ref
S16025 R66522	Christensen (All indications) (Controls unexposed, general population), 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	1.01 [0.80;1.27]	83/2,214 134,023/4,467,848	134,106	2,214		ref
S10045 R36362	Blotière (Controls exposed to Lamotrigine, sick) (Other indications), 2019	Microcephaly (until 24 months of age, identifiable by: Q02; brain MRI; according to the EUROCAT definition)	1st trimester	retrospective cohort (claims database)	exposed to other treatment, sick excluded	Adjustment: No Controls: mixed indications	0.60 [0.02;14.68] ^C excluded (control group)	0/1,671 1/2,997	1	1,671		ref
S10046 R36385	Blotière (Controls unexposed NOS) (Other 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	1.28 [0.08;20.51] ^C	0/1,671 438/1,875,733	438	1,671		ref
S18025 R75961	Margulis (Pregabalin) (Indications other than epilepsy), 2019	Microcephaly (a head circumference of two or more SDs below the mean for gestational age at birth, using a local standard)	during pregnancy (anytime or not specified)	population based cohort retrospective	exposed to other treatment, sick	Adjustment: Yes	0.80 [0.30;2.10]	-/487 -/1,767	-	487		ref
					Total	4 studies	1.01 [0.81;1.26]		137,018	4,821
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

1: Controls unexposed, NOS) (Pregabalin) (Indications NOS; 2: All indications) (Controls unexposed, general population; 3: Controls unexposed NOS) (Other indications; 4: Pregabalin) (Indications other than epilepsy;

Sensitivity analysis

Publication bias and p-hacking diagnosis

funnel plot

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

not enought points

p values plot

Sub-groups analysis using all included studies

excluded 10045, 16068, 19324