Women of childbearing potential/Contraception in males and females: As the potential risk for humans is unknown, effective contraception must be used in women of child bearing potential.
Pregnancy: There are no adequate data from the use of pregabalin in pregnant women.
Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology under Actions). The potential risk for humans is unknown.
Pregabalin should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Breast-feeding: Pregabalin is excreted into human milk. The effect pregabalin on newborns/infants is unknown. A decision must be made whether to discontinue breast-feeding or to discontinue pregabalin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: There are no clinical data on the effects of pregabalin on female fertility.
In a clinical trial to assess the effect of pregabalin on sperm motility, healthy male subjects were exposed to pregabalin at a dose of 600 mg/day. After 3 months of treatment, there were no effects on sperm motility.
A fertility study in female rats has shown adverse reproductive effects. Fertility studies in male rats have shown adverse reproductive and developmental effects. The clinical relevance of these findings is unknown (see Pharmacology: Toxicology under Actions).