Lacosamide and pregnancy: Data from spontaneous and solicited reports

Piero Perucca; Dimitrios Bourikas; P Emanuela Voinescu; Lata Vadlamudi; Daya Chellun; Thomas Kumke; Konrad J Werhahn; Bettina Schmitz

doi:10.1111/epi.17924

Lacosamide and pregnancy: Data from spontaneous and solicited reports

Epilepsia. 2024 May;65(5):1275-1284. doi: 10.1111/epi.17924. Epub 2024 Feb 27.

Authors

Piero Perucca^{1

2}, Dimitrios Bourikas³, P Emanuela Voinescu⁴, Lata Vadlamudi^{5

6}, Daya Chellun⁷, Thomas Kumke⁸, Konrad J Werhahn⁸, Bettina Schmitz⁹

Affiliations

¹ Epilepsy Research Centre, Department of Medicine (Austin Health), University of Melbourne, Melbourne, Victoria, Australia.
² Bladin-Berkovic Comprehensive Epilepsy Program, Austin Health, Melbourne, Victoria, Australia.
³ UCB Pharma, Alimos, Greece.
⁴ Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
⁵ University of Queensland Centre for Clinical Research, University of Queensland, Herston, Queensland, Australia.
⁶ Department of Neurology, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.
⁷ UCB Pharma, Braine-l'Alleud, Belgium.
⁸ UCB Pharma, Monheim am Rhein, Germany.
⁹ Vivantes Humboldt-Klinikum, Berlin, Germany.

PMID: 38411300
DOI: 10.1111/epi.17924

Abstract

Objective: In pregnancy, it is important to balance the risks of uncontrolled epileptic seizures to the mother and fetus against the potential teratogenic effects of antiseizure medications. Data are limited on pregnancy outcomes among patients taking lacosamide (LCM), particularly when taken as monotherapy. The objective of this analysis was to evaluate the pregnancy outcomes of LCM-exposed pregnancies.

Methods: This analysis included all reports in the UCB Pharma pharmacovigilance database of exposure to LCM during pregnancy from spontaneous sources (routine clinical settings) or solicited reports from interventional clinical studies and noninterventional postmarketing studies. Prospective and retrospective reports were analyzed separately.

Results: At the data cutoff (August 31, 2021), there were 202 prospective pregnancy cases with maternal exposure to LCM and known outcomes. Among these cases, 44 (21.8%) patients received LCM monotherapy and 158 (78.2%) received LCM polytherapy. Most patients received LCM during the first trimester (LCM monotherapy: 39 [88.6%]; LCM polytherapy: 143 [90.5%]). From the prospective pregnancy cases with maternal LCM exposure, there were 204 reported outcomes (two twin pregnancies occurred in the polytherapy group). The proportion of live births was 84.1% (37/44) in patients who received LCM as monotherapy, and 76.3% (122/160) for LCM polytherapy. The overall proportion of abortions (for any reason) was 15.9% (7/44) with LCM monotherapy, and 22.5% (36/160) with LCM polytherapy. Congenital malformations were reported in 2.3% (1/44) of known pregnancy outcomes with maternal exposure to LCM monotherapy, and 6.9% (11/160) with polytherapy.

Significance: Our preliminary data do not raise major concerns on the use of LCM during pregnancy. Most pregnancies with LCM exposure resulted in healthy live births, and no new safety issues were identified. These findings should be interpreted with caution, as additional data are needed to fully evaluate the safety profile of LCM in pregnancy.

Keywords: antiseizure medications; congenital malformations; epilepsy; pregnancy outcomes; safety.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Abnormalities, Drug-Induced / epidemiology
Abnormalities, Drug-Induced / etiology
Adult
Anticonvulsants* / adverse effects
Anticonvulsants* / therapeutic use
Epilepsy* / drug therapy
Female
Humans
Infant, Newborn
Lacosamide* / adverse effects
Lacosamide* / therapeutic use
Pharmacovigilance
Pregnancy
Pregnancy Complications* / drug therapy
Pregnancy Complications* / epidemiology
Pregnancy Outcome* / epidemiology
Prospective Studies
Retrospective Studies
Young Adult

Substances

Lacosamide
Anticonvulsants

Grants and funding

UCB Pharma