Guidelines for Using Lacosamide in Pregnancy
Lacosamide can be used during pregnancy when the benefits of seizure control outweigh the potential risks to the fetus, as current evidence does not raise major concerns regarding its use during pregnancy.
Safety Profile and Classification
- Lacosamide is a newer antiseizure medication (ASM) with limited but growing data on use during pregnancy 1, 2.
- While not specifically mentioned in the provided guidelines for pregnancy, lacosamide would fall under FDA pregnancy category C, meaning that it should be used only if potential benefits justify the potential risk to the fetus 3.
- The general principle for medication use during pregnancy applies: the potential risk of a drug and the possible benefit of the therapy must be weighed against each other 3.
Efficacy and Monitoring During Pregnancy
- Therapeutic drug monitoring should begin early in pregnancy as lacosamide concentrations may decrease significantly (by up to 39.9%) during pregnancy compared to non-pregnant levels 4.
- Dose adjustments may be necessary throughout pregnancy to maintain seizure control due to these pharmacokinetic changes 4.
- For epilepsy management during pregnancy, maintaining seizure control is critical as uncontrolled seizures pose risks to both mother and fetus 1.
Available Evidence on Pregnancy Outcomes
- Preliminary data from case reports and observational studies do not suggest lacosamide is a major teratogen 1, 2, 5.
- In a pharmacovigilance database analysis, 84.1% of pregnancies with lacosamide monotherapy exposure resulted in live births, with congenital malformations reported in only 2.3% of cases 1.
- Case reports have documented healthy pregnancy outcomes with lacosamide use throughout pregnancy 6, 5.
Potential Concerns and Monitoring
- Neonatal bradycardia has been observed in some cases of prenatal lacosamide exposure, suggesting cardiac monitoring of the newborn may be warranted 2.
- As with other antiseizure medications, folic acid supplementation is recommended before conception and during pregnancy 6.
- Regular ultrasound monitoring during pregnancy is advisable to assess fetal growth and development 6.
Breastfeeding Considerations
- Limited data suggest that lacosamide use during breastfeeding may be compatible with normal infant development 5.
- Close monitoring of the infant for potential adverse effects is recommended if the mother continues lacosamide while breastfeeding 5.
Clinical Approach
- For women with epilepsy planning pregnancy, pre-conception counseling should include discussion of the risks and benefits of continuing lacosamide 2.
- For pregnant women already on lacosamide, abrupt discontinuation is not recommended due to the risk of breakthrough seizures 1.
- Consider monotherapy at the lowest effective dose when possible, as polytherapy with other antiseizure medications may increase the risk of adverse pregnancy outcomes 1.
Common Pitfalls to Avoid
- Avoiding necessary antiseizure medication during pregnancy due to theoretical concerns, as uncontrolled seizures pose greater risks to both mother and fetus 1.
- Failing to increase the dose of lacosamide during pregnancy despite decreasing plasma concentrations, which may lead to breakthrough seizures 4.
- Not providing adequate folic acid supplementation, which is important for all women with epilepsy of childbearing potential 6.