Lacosamide (All indications) - Medication and Pregnancy KB

Lacosamide (All indications)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
The NAAED (Controls exposed to Lamotrigine, sick) (Indications NOS), 2022	North America and Canada 1997 - 2020	Pregnant women who are taking an antiepileptic drug for any reason and had a liveborn infant, a stillborn infant, or a pregnancy terminated because of a fetal abnormality and enrolled as 'pure' or 'traditional' enrollees.	Infants of pregnant women who used lacosamide as monotherapy, during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Infants of pregnant women who used lamotrigine as monotherapy, during the first trimester.	64 / 2333	Study design completed with the publication of Hernández-Díaz et al. 2012. Data extracted from the North American AED pregnancy registry web-site. Indications not specified.
The NAAED (Controls unexposed, disease free) (Indications NOS), 2022	North America and Canada 1997 - 2020	Pregnant women who are taking an antiepileptic drug for any reason and had a liveborn infant, a stillborn infant, or a pregnancy terminated because of a fetal abnormality and enrolled as 'pure' or 'traditional' enrollees.	Infants of pregnant women who used lacosamide as monotherapy, during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Infants of pregnant women, not taking an antiepileptic drug and without epilepsy, who were recruited from among the friends and family members of the enrolled women taking an antiepileptic drug.	64 / 1201	Study design completed with the publication of Hernández-Díaz et al. 2012. Data extracted from the North American AED pregnancy registry website. Indications not specified. Internal control group reported rather than the external (for relevance purpose).
Tomson (Lacosamide), 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 lacosamide 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.	8 / 2514	EURAP registry: potential overlap.

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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