Neugaba Use In Pregnancy & Lactation

Fertility: There is no effect on fertility in animal studies (see Pharmacology: Toxicology: Preclinical safety data: Impairment of fertility under Actions).
Pregnancy: Gabapentin crosses the human placenta.
The risk of birth defects is increased by a factor of 2-3 in the offspring of mothers treated with an antiepileptic medicinal product.
Data from an observational study, which included more than 1,700 pregnancies exposed to gabapentin based on routinely collected data from administrative and medical registers in Denmark, Finland, Norway, and Sweden, do not suggest substantially increased risks of major congenital malformations, adverse birth outcomes, or abnormal postnatal neurodevelopmental outcomes in gabapentin-exposed pregnancies.
For major congenital malformations, the adjusted prevalence ratios (aPRs) and 95% confidence intervals (CI) in the standard meta-analysis for first trimester gabapentin exposed vs. unexposed to antiepileptic drugs was 0.99 (0.80-1.23).
Overall, there were no statistically significant findings for stillbirth, small for gestational age, low Apgar score, and microcephaly. The aPRs were 1.21 (1.02-1.44) for low birth weight, 1.16 (1.00-1.35) for preterm birth.
In pediatric population exposed in utero, the study did not provide evidence of an increased risk for neurodevelopmental outcomes, such as attention deficit hyperactivity disorder (ADHD), autism spectrum disorders (ASD), and intellectual disabilities.
Neonatal withdrawal syndrome has been reported in newborns exposed in utero to gabapentin. Co-exposure to gabapentin and opioids during pregnancy may increase the risk of neonatal withdrawal syndrome.
Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data: Teratogenesis under Actions). Gabapentin should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the fetus.
Lactation: Gabapentin is excreted in human milk. Because the effect on the nursing infant is unknown, caution should be exercised when gabapentin is administered to a nursing mother. Gabapentin should be used in nursing mothers only if the benefits clearly outweigh the risks.