Safety of Lacosamide During Pregnancy
Lacosamide appears to have a relatively favorable safety profile during pregnancy, with preliminary data showing no major safety concerns, though more comprehensive evidence is still needed for definitive conclusions.
Current Evidence on Lacosamide in Pregnancy
Safety Data
- The most recent data from 2024 shows that among 202 prospective pregnancy cases with maternal exposure to lacosamide:
- 84.1% of pregnancies with lacosamide monotherapy resulted in live births 1
- Congenital malformations were reported in only 2.3% of pregnancies with lacosamide monotherapy, compared to 6.9% with polytherapy 1
- These preliminary findings do not raise major safety concerns for lacosamide use during pregnancy
Pharmacokinetic Considerations
- Lacosamide metabolism increases during pregnancy, leading to decreased serum concentrations:
Case Reports
- Several case reports document successful pregnancies with lacosamide:
Management Recommendations
Seizure Control vs. Medication Risk
- For women with epilepsy, maintaining seizure control during pregnancy is critical:
- Uncontrolled seizures pose significant risks to both mother and fetus
- The risks of seizures generally outweigh the potential teratogenic effects of most antiseizure medications
Monitoring During Pregnancy
- Regular monitoring of lacosamide levels is recommended, particularly in the second and third trimesters
- Dose adjustments may be necessary as metabolism increases during pregnancy
- Fetal monitoring with ultrasound is recommended to assess fetal growth and detect any potential abnormalities
Breastfeeding Considerations
- Limited data suggests lacosamide may be compatible with breastfeeding 4
- No reported adverse effects in breastfed infants of mothers taking lacosamide
Important Caveats
- Most data on lacosamide in pregnancy comes from observational studies and case reports
- The majority of pregnant women in studies received lacosamide as part of polytherapy (78.2%) rather than monotherapy (21.8%) 1
- Potential neonatal effects have been reported, including bradycardia in 3 neonates that might be related to prenatal lacosamide exposure 5
- Long-term neurodevelopmental outcomes data is still limited
Conclusion
While preliminary data is encouraging regarding lacosamide's safety profile during pregnancy, the evidence base is still developing. The decision to use lacosamide during pregnancy should balance seizure control against potential risks, with close monitoring throughout pregnancy and consideration of dose adjustments as needed.