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Anagrelide Pregnancy and Breastfeeding Warnings

Anagrelide is also known as: Agrylin

Anagrelide Pregnancy Warnings

Anagrelide has been assigned to pregnancy category C by the FDA. Studies performed in pregnant rats and rabbits have revealed no evidence of impaired fertility or harm to the fetus due to anagrelide. A fertility and reproductive performance study performed in female rats revealed that oral doses of 60 mg/kg/day or higher disrupted implantation and exerted adverse effect on embryo/fetal survival. In addition, a perinatal and postnatal study performed in female showed that oral doses of 60 mg/kg/day or higher produced delay or blockage of parturition, deaths of nondelivering pregnant dams and their fully developed fetuses, and increased mortality in the pups born. There are no controlled data in human pregnancy. Anagrelide is only recommended for use during pregnancy when benefit outweighs risk.

Five women became pregnant while on anagrelide treatment at doses of 1 to 4 mg/day. Treatment was stopped as soon as it was realized that they were pregnant. All delivered normal, healthy babies. Anagrelide is not recommended in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. Women of childbearing potential should be instructed that they must not be pregnant and that they should use contraception while taking anagrelide. Anagrelide may cause fetal harm when administered to a pregnant woman.

Anagrelide Breastfeeding Warnings

There are no data on the excretion of anagrelide into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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