Neumogine Use In Pregnancy & Lactation

Risk related to antiepileptic drugs in general: Specialist advice should be given to women who are of childbearing potential. Antiepileptic treatment should be reviewed when a woman is planning to become pregnant. In women being treated for epilepsy, sudden discontinuation of antiepileptic drug (AED) therapy should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.
Monotherapy should be used whenever possible because therapy with multiple AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics.
Risk related to lamotrigine: Pregnancy: A large amount of epidemiological study data from more than 12,700 pregnancies exposed to lamotrigine monotherapy, including more than 9,100 pregnancies exposed during the first trimester, do not indicate that lamotrigine therapy at maintenance doses is associated with an increased risk of major congenital malformations.
Studies investigating the effect of doses higher than the usual maintenance dose of 100 - 200 mg per day on the risk of major congenital malformations have shown conflicting results. Some studies did not find evidence of a dose-response effect, however data from the International Registry of Antiepileptic Drugs and Pregnancy (EURAP) showed a statistically significant increase in the rate of major congenital malformations with dose of lamotrigine ≥325 mg per day, compared with doses <325 mg per day (OR 1.68, 95% CI 1.01 - 2.80). Therefore, if therapy with lamotrigine is considered necessary during pregnancy, the lowest possible therapeutic dose is recommended.
Lamotrigine has a slight inhibitory effect on dihydrofolic acid reductase. Since folic acid has a protective effect on the risk of neural tube defects folic acid supplementation when planning pregnancy and during early pregnancy is recommended.
Physiological changes during pregnancy may affect lamotrigine levels and/or therapeutic effect. There have been reports of decreased lamotrigine plasma levels during pregnancy with a potential risk of loss of seizure control. After birth lamotrigine levels may increase rapidly with a risk of dose related adverse events. Therefore, lamotrigine serum concentrations should be monitored before, during and after pregnancy, as well as shortly after birth. If necessary, the dose should be adapted to maintain the lamotrigine serum concentration at the same level as before pregnancy, or adapted according to clinical response. In addition, dose related undesirable effects should be monitored after birth.
Animal studies have shown developmental toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Lactation: Lamotrigine has been reported to pass into breast milk in highly variable concentrations, resulting in total lamotrigine levels in infants of up to approximately 50% of the mother's. Therefore, in some breast-fed infants, serum concentrations of lamotrigine may reach levels at which pharmacological effects occur.
The potential benefits of breast-feeding should be weighed against the potential risk of adverse effects occurring in the infant. Should a woman decide to breast-feed while on therapy with lamotrigine, the infant should be monitored for adverse effects, such as sedation, rash and poor weight gain.
Fertility: Animal experiments did not reveal impairment of fertility by lamotrigine (see Pharmacology: Toxicology: Preclinical safety data under Actions).