#33 Lacosamide use during pregnancy – An evaluation of the German embryotox database

Hoeltzenbein, Maria; Slimi, Sofia; Fietz, Anne‐Katrin; Onken, Marlies; Dathe, Katarina; Schaefer, Christof

doi:10.1016/j.reprotox.2019.05.039

Cited by 3 publications

(4 citation statements)

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“…18–31 The other publications on lacosamide included nine case series, 32–40 one retrospective cohort study, 41 and two pharmacovigilance safety reports. 42,43…”

Section: Resultsmentioning

confidence: 99%

“…[18][19][20][21][22][23][24][25][26][27][28][29][30][31] The other publications on lacosamide included nine case series, [32][33][34][35][36][37][38][39][40] one retrospective cohort study, 41 and two pharmacovigilance safety reports. 42,43 Ben-Menachem et al reported in a multicenter open-label trial that two individuals became pregnant. Lacosamide monotherapy was discontinued at 7 weeks and 17 weeks after positive pregnancy tests.…”

Section: Synthesis Of Results From Included Studiesmentioning

confidence: 99%

“…41 There were two pharmacovigilance studies with data from the Berlin Embryotox pharmacovigilance center and UCB global safety database. 42,43 Hoeltzenbein et al reported the pregnancy outcomes of 52 pregnancies with lacosamide exposure; three (5.76%) were born prematurely and there were 12 (23%) cases of fetal loss (three spontaneous abortions, eight elective termination of pregnancy and one stillbirth). Golembesky et al reported that out of 101 pregnant people exposed to lacosamide, there were 26 (25.7%) cases of fetal loss (11 spontaneous and 15 induced abortions).…”

Section: Synthesis Of Results From Included Studiesmentioning

confidence: 99%

“…Pharmacovigilance studies included 153 people, highlighting the increasing use. 42,43 However, without a comparator, determining if the 5.76% preterm births in Hoeltzenbein et al or the fetal loss of 23% and 25.7% in Hoeltzenbein et al and Golembesky et al are related to lacosamide is currently not possible.…”

Section: Discussionmentioning

confidence: 99%

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Third generation antiseizure medications exposure during pregnancy and neonatal adverse birth outcomes: A systematic review

Goubran,

Okunnu,

Lavu

et al. 2024

Science Progress

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Background: Third generation antiseizure medications (ASMs) are currently used for seizure control as well as several other indications, including pain management and psychiatric disorders. As a result, maternal exposure to third generation ASMs during pregnancy has become increasingly prevalent. The current systematic review aimed to summarize the published evidence on third generation ASMs and their effect on preterm birth, cesarean section (c-section) and fetal loss. Methods: The following databases were searched: Medline, Embase, International Pharmaceutical Abstracts, Cochrane Library and Scopus until September 2022. Results: We screened 2987 studies, and identified 32 studies or case reports for inclusion, however only one study utilized a control group. Narrative systematic evidence synthesis was conducted for brivaracetam, eslicarbazepine, fosphenytoin, lacosamide and perampanel. Conclusion: Due to the scarcity and quality of published studies, drawing clear-cut conclusions regarding third generation ASMs and the outcomes of interest is challenging. More comparative safety studies focusing on neonatal safety of third generation ASMs in pregnancy are essential.

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“…18–31 The other publications on lacosamide included nine case series, 32–40 one retrospective cohort study, 41 and two pharmacovigilance safety reports. 42,43…”

Section: Resultsmentioning

confidence: 99%

Section: Synthesis Of Results From Included Studiesmentioning

confidence: 99%

Section: Synthesis Of Results From Included Studiesmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Third generation antiseizure medications exposure during pregnancy and neonatal adverse birth outcomes: A systematic review

Goubran,

Okunnu,

Lavu

et al. 2024

Science Progress

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Valproate

2019

Reactions Weekly

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Safety and Tolerability of Lacosamide in Patients With Epilepsy: A Systematic Review and Meta-Analysis

et al. 2021

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Background: As a third-generation antiseizure medication (ASM), lacosamide (LCM) is recommended worldwide for patients with epilepsy. We aimed to provide more conclusive evidence for the safety and tolerability of LCM in patients with epilepsy.Methods: A systematic search was performed on MEDLINE, Embase, Cochrane Library, CBM, CNKI, IDB, VIP Database, and Wanfang Database from inception to 2021 March, and all studies assessing the safety of LCM were included. A meta-analysis was performed for safety data of LCM.Results: Eighty-three studies involving 12268 populations (11 randomized clinical trials (RCTs), 16 cohort studies, 53 case series, and 3 case reports) were included in our study. Meta-analysis of the total incidence of adverse events (AEs) of LCM was 38.7% [95% CI (35.1%, 45.8%); n=75 studies]. Incidence of withdrawal due to AEs was 10.8% [95% CI (9.1%, 12.6%); n=56 studies], and incidence of serious adverse events (SAEs) was 6.5% [95% CI (4.0%, 8.9%); n=13 studies]. Most AEs were in the nervous system and digestive system. The most common AEs were sedation (15.8%), dizziness (15.7%), fatigue (9.4%), and nausea/vomiting (9.3%). For children, the total incidence of AEs of LCM was 32.8% [95% CI (21.6%, 44.0%); n=16 studies], and the most common AEs were dizziness (8.6%), nausea/vomiting (8.6%), and somnolence (6.8%).Conclusion: Lacosamide is generally safe and well tolerated in patients with epilepsy. Common AEs were sedation, dizziness, and fatigue. It is necessary to pay more attention to the prevention and management of these AEs and conduct more large-scale and high-quality studies to update safety data.

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#33 Lacosamide use during pregnancy – An evaluation of the German embryotox database

Cited by 3 publications

References 0 publications

Third generation antiseizure medications exposure during pregnancy and neonatal adverse birth outcomes: A systematic review

Third generation antiseizure medications exposure during pregnancy and neonatal adverse birth outcomes: A systematic review

Valproate

Safety and Tolerability of Lacosamide in Patients With Epilepsy: A Systematic Review and Meta-Analysis

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