Pregnancy Category C: Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity, including lethality, growth retardation and nervous and reproductive system functional impairment, were observed in the offspring of rats and rabbits given pregabalin during pregnancy at doses that produced plasma pregabalin exposures (AUC) ≥5 times human exposure at the maximum recommended dose of 600 mg/day. There are no adequate and well-controlled studies in pregnant women. Pregabalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known if pregabalin is excreted in human milk; it is, however, present in the milk of rats. Because many drugs are excreted in human milk, and because of the potential for tumorigenicity shown for pregabalin in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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