Zonisamide (Epilepsy) - Medication and Pregnancy KB

Zonisamide (Epilepsy)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Hernández-Díaz (Zonisamide), 2017	United States and Canada 1997 - 2017	Singleton, nonmalformed liveborn infants whose mothers had complete follow-up data.	Infants born to women who used zonisamide in monotherapy throughout pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Infants born to women who used lamotrigine in monotherapy throughout pregnancy.	125 / 1799	'Most women used their AED throughout pregnancy. The exception was topiramate'. The main indications for AED were epilepsy (91%).
Hernández-Díaz (Zonisamide) (Controls exposed to Lamotrigine, sick), 2012	North America and Canada 1997 - 2011	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 zonisamide for epileptic indication as monotherapy, during the first 4 lunar months after the last menstrual period (equal 16 weeks of gestation). (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 for mixed indications as monotherapy, during the first 4 lunar months after the last menstrual period (equal 16 weeks of gestation).	90 / 1562	Less than 90% of women are taking Lamotrigine for epilepsy.
Hernández-Díaz (Zonisamide) (Controls exposed to Lamotrigine, sick), 2014	United States and Canada 1997 - 2012	Women who had singleton, nonmalformed liveborns and who had complete follow-up data.	Infants of women exposed to zonisamide for epileptic indication as monotherapy throughout pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Infants of women exposed to lamotrigine for mixed indications as monotherapy throughout pregnancy.	98 / 1581	Less than 90% of women are taking Lamotrigine for epilepsy. A more recent publication Hernández-Díaz 2017 gives a better review of the outcome 'small for gestational age'. Most women used their antiepileptic drug throughout pregnancy.
Hernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2012	North America and Canada 1997 - 2011	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 zonisamide for epileptic indication as monotherapy, during the first 4 lunar months after the last menstrual period (equal 16 weeks of gestation). (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.	90 / 442
Hernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2014	United States and Canada 1997 - 2012	Women who had singleton, nonmalformed liveborns and who had complete follow-up data.	Infants of women exposed to zonisamide as monotherapy throughout pregnancy. (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 drugs and without epilepsy who had been recruited among the friends and relatives of antiepileptic drugs-exposed participants.	98 / 457	Most women used their antiepileptic drug throughout pregnancy. A more recent publication (Hernández-Díaz 2017) gives a better review for the outcome 'small for gestational age'.
Meador (Zonisamide) (Controls exposed to Lamotrigine, sick), 2021	US 2012 - 2016	Pregnant (gestational age of 20 weeks or less) women with epilepsy and healthy women were recruited from the 20 epilepsy practices and through referral from obstetricians and other physicians as well as self-referral.	Children with epileptic mothers using zonisamide monotherapy in the third trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Children with epileptic mothers using lamotrigine monotherapy in the third trimester.	11 / 93	Exclusion criteria included history of psychogenic nonepileptic spells, expected IQ of less than 70, other major medical illness, and switching of ASMs in pregnancy before enrollment.
Meador (Zonisamide) (Controls exposed to Lamotrigine, sick), 2020	US 2012 - 2016	Pregenant women with epilepsy were recruited primarily from the clinical populations at the 20 MONEAD sites, but also via referral from physicians, as well as self-referral. They were ages 14–45 years and ≤20 weeks gestational age.	Children born to pregnant women with epilepsy exposed to zonisamide 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 Children born to pregnant women with epilepsy exposed to lamotrigine monotherapy during the first trimester.	13 / 113
Meador (Zonisamide) (Controls unexposed, disease free), 2021	US 2012 - 2016	Pregnant (gestational age of 20 weeks or less) women with epilepsy and healthy women were recruited from the 20 epilepsy practices and through referral from obstetricians and other physicians as well as self-referral.	Children with epileptic mothers using zonisamide monotherapy in the third trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Children of healthy women.	11 / 106	Exclusion criteria included history of psychogenic nonepileptic spells, expected IQ of less than 70, other major medical illness, and switching of ASMs in pregnancy before enrollment.
Meador (Zonisamide) (Controls unexposed, disease free), 2020	US 2012 - 2016	Pregenant women with epilepsy were recruited primarily from the clinical populations at the 20 MONEAD sites, but also via referral from physicians, as well as self-referral. They were ages 14–45 years and ≤20 weeks gestational age.	Children born to pregnant women with epilepsy exposed to zonisamide monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Children born to healthy pregnant women.	13 / 106
Meador (Zonisamide) (Controls unexposed, sick), 2020	US 2012 - 2016	Pregenant women with epilepsy were recruited primarily from the clinical populations at the 20 MONEAD sites, but also via referral from physicians, as well as self-referral. They were ages 14–45 years and ≤20 weeks gestational age.	Children born to pregnant women with epilepsy exposed to zonisamide monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Children born to pregnant women with epilepsy with no antiepileptic drug use.	13 / 15
Tomson (Zonisamide), 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 zonisamide 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.	9 / 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.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

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

master protocol