From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Lamotrigine Use During Pregnancy
- Lamotrigine is considered a relatively safe option for pregnant women, with studies suggesting a low risk of major congenital anomalies 1, 2.
- Pregnancy registries have consistently demonstrated lamotrigine to be among the safest medications for a developing fetus, both in terms of fetal malformations and postpartum cognitive development 2.
- A retrospective analysis from an urban maternal mental health centre in New Zealand found that lamotrigine was an effective treatment option for maintenance of bipolar illness in women of childbearing age, with no significant adverse outcomes reported 3.
- A systematic review and meta-analysis found that lamotrigine monotherapy had a slightly weaker ability to control seizures during pregnancy compared to other antiseizure medications, but had a lower occurrence rate of adverse pregnancy outcomes 4.
Safety Profile and Risk of Malformations
- Studies have reported differing results on the safety of lamotrigine use during pregnancy, with some suggesting a low risk of malformations and others reporting contradictory results 1, 5.
- The North American Antiepileptic Drug Pregnancy Registry suggested an increased risk for oral clefts, but other studies have found no significant association between lamotrigine use and oral clefts 1.
- Human pregnancy registries have been maintained to establish the safety of antiepileptic drugs during pregnancy, and have provided valuable information on the risks and benefits of lamotrigine use during pregnancy 5.
Clinical Considerations
- Lamotrigine may be a reasonable alternative for pregnant women when clinically indicated, particularly for those with epilepsy or bipolar disorder 1, 2.
- The dose of lamotrigine may need to be adjusted during pregnancy, as the median dose in the beginning of pregnancy was 200 mg/d and was increased in 29% of cases 1.
- Breastfeeding is considered safe for women taking lamotrigine, with no significant complications reported in babies who were breastfed while their mothers received uninterrupted treatment with lamotrigine 3.