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Pregnancy: There is a limited amount of data on the use of pregabalin in pregnant women. Data from an observational study, which included more than 2,700 pregnancies exposed to pregabalin based on routinely collected data from administrative and medical registers in Denmark, Finland, Norway, and Sweden, is as follows: Major congenital malformations (MCM): The risk of MCM among the paediatric population exposed to pregabalin in the first trimester was slightly higher compared to unexposed population (adjusted prevalence ratio and 95% confidence interval: 1.14 (0.96-1.35), and compared to population exposed to lamotrigine (1.29 (1.01-1.65)) or to duloxetine (1.39 (1.07-1.82).
Birth and post-natal neurodevelopmental outcomes: There were no statistically significant findings for stillbirth, low birth weight, preterm birth, small for gestational age (SGA), low Apgar score at 5 minutes, and microcephaly. Adjusted prevalence ratios (aPRs, and 95% confidence intervals) results for the metaanalysis for stillbirth, low birth weight, preterm birth, SGA, low Apgar score at 5 minutes, and microcephaly for pregabalin-exposed compared to unexposed to antiepileptic drugs (AEDs) of 1.72 (1.02-2.91), 1.05 (0.91-1.21), 1.13 (0.99-1.29), 1.21 (1.01-1.44), 1.18 (0.95-1.48), and 1.09 (0.88-1.36) respectively.
In paediatric population exposed in utero, the study did not provide evidence of an increased risk for attention deficit hyperactivity disorder (ADHD), autism spectrum disorders (ASD), and intellectual disabilities (ID). In the meta-analyses of the neurodevelopmental outcomes (ADHD, ASD, and ID), results for ADHD, ASD, and ID for pregabalin-exposed compared to unexposed to AEDs were 1.32 (1.04-1.67), 1.00 (0.68-1.47), and 1.03 (0.80-1.32) respectively.
Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Pregabalin should not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus. Effective contraception must be used in women of child-bearing potential.
Lactation: Pregabalin is excreted in the milk of lactating women (see Pharmacology: Pharmacokinetics under Actions). As the safety of pregabalin in infants is not known, breast-feeding is not recommended during treatment with pregabalin. A decision must be made whether to discontinue breast-feeding or to discontinue from pregabalin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
