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Pregnancy: There is limited amount of data on the use of LYRICA (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 follow: Major congenital malformations: The adjusted prevalence ratios (aPRs) and 95% confidence intervals (CI) in the standard meta-analysis for first-trimester pregabalin monotherapy-exposed vs. unexposed to anti-epileptic drugs was 1.14 (0.96-1.35).
The analyses on specific malformations showed higher risks for malformations of the nervous system, the eye, orofacial clefts, urinary malformations and genital malformations, but numbers were small and estimates imprecise.
Birth and postnatal neurodevelopmental outcomes: There were no statistically significant findings for stillbirth, low birth weight, preterm birth, small for gestational age, low Apgar score, and microcephaly.
In pediatric 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.
Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Lyrica 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 childbearing 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.
