Zonisamide safety in pregnancy: Data from the UK and Ireland epilepsy and pregnancy register

McCluskey, Gavin; Kinney, M O; Russell, Aline; Smithson, W Henry; Parsons, Linda M.; Morrison, PJ; Bromley, Rebecca; Mackillop, Lucy; Heath, Craig; Liggan, Brenda; Murphy, Sinéad; Delanty, Norman; Irwin, B.; Campbell, Ellen; Morrow, Jim; Hunt, S.; Craig, John

doi:10.1016/j.seizure.2021.07.002

Cited by 19 publications

(15 citation statements)

References 9 publications

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“…Furthermore, there was a high rate of infants born SGA. 194 Low birth weight and length were also reported in 98 zonisamide-exposed pregnancies. 195 …”

Section: Management Of Epilepsy During Pregnancy and Anti-seizure Med...mentioning

confidence: 93%

“…Furthermore, the NAAPR reported a risk of MCM of 0.9% in 218 pregnancies. 96 Instead, the UKIEPR 194 reported data on 112 cases of first-trimester exposure to zonisamide, including 26 in monotherapy; from those, there were 3 MCMs in monotherapy and 5 in polytherapy. Furthermore, there was a high rate of infants born SGA.…”

Section: Management Of Epilepsy During Pregnancy and Anti-seizure Med...mentioning

confidence: 99%

See 1 more Smart Citation

Treatment and care of women with epilepsy before, during, and after pregnancy: a practical guide

Nucera

Brigo

Trinka

et al. 2022

Ther Adv Neurol Disord

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Women with epilepsy (WWE) wishing for a child represent a highly relevant subgroup of epilepsy patients. The treating epileptologist needs to delineate the epilepsy syndrome and choose the appropriate anti-seizure medication (ASM) considering the main goal of seizure freedom, teratogenic risks, changes in drug metabolism during pregnancy and postpartum, demanding for up-titration during and down-titration after pregnancy. Folic acid or vitamin K supplements and breastfeeding are also discussed in this review. Lamotrigine and levetiracetam have the lowest teratogenic potential. Data on teratogenic risks are also favorable for oxcarbazepine, whereas topiramate tends to have an unfavorable profile. Valproate needs special emphasis. It is most effective in generalized seizures but should be avoided whenever possible due to its teratogenic effects and the negative impact on neuropsychological development of in utero-exposed children. Valproate still has its justification in patients not achieving seizure freedom with other ASMs or if a woman decides to or cannot become pregnant for any reason. When valproate is the most appropriate treatment option, the patient and caregiver must be fully informed of the risks associated with its use during pregnancies. Folate supplementation is recommended to reduce the risk of major congenital malformations. However, there is insufficient information to address the optimal dose and it is unclear whether higher doses offer greater protection. There is currently no general recommendation for a peripartum vitamin K prophylaxis. During pregnancy most ASMs (e.g. lamotrigine, oxcarbazepine, and levetiracetam) need to be increased to compensate for the decline in serum levels; exceptions are valproate and carbamazepine. Postpartum, baseline levels are reached relatively fast, and down-titration is performed empirically. Many ASMs in monotherapy are (moderately) safe for breastfeeding and women should be encouraged to do so. This review provides a practically oriented overview of the complex management of WWE before, during, and after pregnancy.

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“…Furthermore, there was a high rate of infants born SGA. 194 Low birth weight and length were also reported in 98 zonisamide-exposed pregnancies. 195 …”

Section: Management Of Epilepsy During Pregnancy and Anti-seizure Med...mentioning

confidence: 93%

Section: Management Of Epilepsy During Pregnancy and Anti-seizure Med...mentioning

confidence: 99%

Treatment and care of women with epilepsy before, during, and after pregnancy: a practical guide

Nucera

Brigo

Trinka

et al. 2022

Ther Adv Neurol Disord

View full text Add to dashboard Cite

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“…De los 37 estudios seleccionados para la síntesis cualitativa, uno fue publicado en 2022 9 , tres en 2021 [10][11][12] , seis en 2020 [13][14][15][16][17][18] , siete en 2019 [19][20][21][22][23][24][25] , siete en 2018 [26][27][28][29][30][31][32] , nueve en 2017 6,[33][34][35][36][37][38][39][40] y cuatro en 2016 [41][42][43][44] , proviniendo de 14 países repartidos por Asia, Europa, América del Norte y Oceanía.…”

Section: Resultsunclassified

Fármacos antiepilépticos usados en el embarazo y sus consecuencias sobre los resultados fetales: una revisión de la literatura

Ojeda-Olivares¹,

Venegas-GuÓeicha²,

Gutiérrez-Valenzuela³

et al. 2023

RECHOG

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Los riesgos teratogénicos ocasionados por la exposición intrauterina a fármacos antiepilépticos (FAE) son conocidos, por lo que su prescripción se mantiene bajo estricto control. Describir los efectos adversos fetales de la exposición a FAE durante la gestación, reportados en la literatura durante el período 2016-2022. Revisión sistematizada de estudios que reportaron los efectos adversos fetales inducidos por la exposición a FAE en mujeres embarazadas en tratamiento por diagnósticos neurológicos, principalmente de epilepsia.

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“…1). [33][34][35][36][37][38][39][40] When considering the results of each of the pregnancy registries (►Table 3) and in turn making comparisons, it is important to remember each registry study has its own strengths and weaknesses (►Table 4). 41 The key concerns are possible enrolment bias and representativeness of real life, but other concerns include nonstandardized data collection across different studies (epilepsy cause, epilepsy syndrome, seizure types); lack of drug concentration measurements as part of the protocols; certain confounders not being assessed; and different approaches to determining outcomes in nonblinded studies.…”

Section: Global Pregnancy Registries and Post-marketing Surveillancementioning

confidence: 99%

“…However, they subsequently found zonisamide was associated with an increased rate of low birth weight, with 14% of infants being small for gestational age, compared to 7 to 12% with lamotrigine. The UK and Ireland Registry 36 recently reported an MCM rate of 13% (95% CI: 4.5–32.1) for monotherapy zonisamide, based on three cases from 26 exposures. Small numbers clearly limit interpretation.…”

Section: Monotherapymentioning

confidence: 99%

Preventing Teratogenicity in Women with Epilepsy

2022

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Over the last 50 years there has been a significant increase in our understanding of the issues faced by women with epilepsy, in both planning and undertaking pregnancy. The risks of teratogenicity associated with antiseizure medications have emerged slowly. The major pregnancy registers have substantially contributed to our knowledge about teratogenic risk associated with the commonly used antiseizure medications. However, there are substantial gaps in our knowledge about the potential risks associated with many third-generation drugs. The remit of the pregnancy registers and the wider research focus has moved beyond anatomical major congenital malformations. Increasingly neurodevelopmental and behavioral abnormalities have been investigated after in utero exposure to antiseizure medications. Public health approaches can help reduce the risk of teratogenicity. However, neurologists still have a vital role in reducing the risk of teratogenicity at an individual level for women attending their clinic. They also have responsibility to ensure that women with epilepsy are aware of the rationale for the different available options.

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Zonisamide safety in pregnancy: Data from the UK and Ireland epilepsy and pregnancy register

Cited by 19 publications

References 9 publications

Treatment and care of women with epilepsy before, during, and after pregnancy: a practical guide

Treatment and care of women with epilepsy before, during, and after pregnancy: a practical guide

Fármacos antiepilépticos usados en el embarazo y sus consecuencias sobre los resultados fetales: una revisión de la literatura

Preventing Teratogenicity in Women with Epilepsy

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