Safety-Related Labeling Changes

In animal studies lamotrigine was not teratogenic in animal reproductive studies involving mice, rats, and rabbits using oral doses that were 125, 25, and 30 mg/kg, respectively, during organogenesis. However, maternal toxicity and secondary fetal toxicity consisting of increased mortality, decreased body weight, increased structural variation, neurobehavioral abnormalities at doses lower than those administered clinically. Lamotrigine decreased fetal folate concentrations in rats, an effect known to be associated with adverse pregnancy outcomes in animals and humans

Trade Name

Lamictal

Updated Section

4.6. Fertility, pregnancy and lactation

Month

Oct,2022