Pregabalin (Epilepsy) - Medication and Pregnancy KB

Pregabalin (Epilepsy)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Dreier (Controls exposed to LTG), 2023	Denmark, Finland, Iceland, Norway, and Sweden. 1996 - 2017	Live-born singleton children of mothers with epilepsy in Denmark (1997-2017), Finland (1996- 2016), Iceland (2004-2017), Norway (2005-2017), and Sweden (2006-2017).	Children prenatally exposed to pregabalin monotherapy, i.e whose mother had redeemed 1 or more prescriptions during the exposure window, which was defined as 30 days before the first day of the last menstrual period (estimated using gestational age in days at birth) until the date of birth.	exposed to other treatment, sick Children prenatally exposed to lamotrigine monotherapy, i.e whose mother had redeemed 1 or more prescriptions during the exposure window, which was defined as 30 days before the first day of the last menstrual period (estimated using gestational age in days at birth) until the date of birth.	120 / 5288
Dreier (Controls unexposed, sick), 2023	Denmark, Finland, Iceland, Norway, and Sweden. 1996 - 2017	Live-born singleton children of mothers with epilepsy in Denmark (1997-2017), Finland (1996- 2016), Iceland (2004-2017), Norway (2005-2017), and Sweden (2006-2017).	Children prenatally exposed to pregabalin monotherapy, i.e whose mother had redeemed 1 or more prescriptions during the exposure window, which was defined as 30 days before the first day of the last menstrual period (estimated using gestational age in days at birth) until the date of birth.	unexposed, sick Children not prenatally exposed to antiseizure medication.	120 / 22203
Tomson (Pregabalin), 2018	42 countries 1999 - 2016	Pregnancies registered in the database during the study period who had been exposed to antiepileptic drug monotherapy and had complete follow-up data up to 1 year. They were enrolled within gestation week 16 and before fetal outcome is known.	Offspring exposed in utero to pregabalin monotherapy during the first trimester and born from epileptic mothers. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Offspring exposed in utero to lamotrigine monotherapy during the first trimester and born from epileptic mothers.	4 / 2514	This study is an update of Tomson's 2011 publication. They excluded from the current analysis pregnancies occurring in women without epilepsy. EURAP registry: potential overlap.
Vajda (Pregabalin) (Controls exposed to Lamotrigine, sick), 2019	Australia 1999 - 2018	Pregnant women taking antiepileptic drugs for any indications or not treated with antiepileptic drugs in at least the first half of pregnancy.	Offsprings born from women nearly always with epilepsy exposed to pregabalin in monotherapy in at least the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Offsprings born from women nearly always with epilepsy exposed to lamotrigine in monotherapy in at least the first trimester of pregnancy.	1 / 406	Women with epilepsy accounted for 98.3%. Study design partly completed with Vajda 2013.
Vajda (Pregabalin) (Controls unexposed, sick), 2019	Australia 1999 - 2018	Pregnant women taking antiepileptic drugs for any indications or not treated with antiepileptic drugs in at least the first half of pregnancy.	Offsprings born from women nearly always with epilepsy exposed to pregabalin in monotherapy in at least the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Offsprings born from women nearly always with epilepsy not treated with antiepileptic drugs in at least the first half of pregnancy.	1 / 176	Women with epilepsy accounted for 98.3%. Study design partly completed with Vajda 2013.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

Warning! There are no case-control studies available for this drug.

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