Pregnancy and Nursing Mothers

No evidence for impaired fertility or harm to the fetus has been attributed to bivalirudin in teratogenicity studies performed on rats and rabbits using higher doses than recommended for human use (The Medicines Company, 2005). There are no well-controlled studies in pregnant women, however. Given the potential for adverse effects on the neonate and the potential for increased maternal bleeding, bivalirudin and aspirin (normally used together) should be used only if clearly needed (The Medicines Company, 2005). Caution is also advised when giving bivalirudin to nursing women, as it is not known whether bivalirudin crosses the placenta or whether it is excreted in breast milk (Carswell and Plosker, 2002).

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