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No clinical study has been conducted in breast-feeding women.
Pregnancy: Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions). Because animal reproduction studies are not always predictive of a human response, Effient should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Lactation: It is unknown whether prasugrel is excreted in human breast milk. Animal studies have shown excretion of prasugrel in breast milk. The use of prasugrel during breastfeeding is not recommended.
Fertility: Prasugrel had no effect on fertility of male and female rats at oral doses up to an exposure 240 times the recommended daily human maintenance dose (based on mg/m2).
