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Leuprolide Pregnancy and Breastfeeding Warnings

Leuprolide is also known as: Eligard, Lupron, Lupron Depot, Lupron Depot 11.25 mg, Lupron Depot 3.75 mg, Lupron Depot-Gyn, Lupron Depot-PED, Viadur

Leuprolide Pregnancy Warnings

Leuprolide has been assigned to pregnancy category X by the FDA. Animal studies have revealed evidence an increase in major fetal abnormalities, increased fetal mortality, an decreased fetal weights. There are no controlled data in human pregnancy. Inhibition of gonadotropin secretion may adversely affect pregnancy outcome. Leuprolide use during pregnancy is considered contraindicated.

The manufacturer has stated that leuprolide is contraindicated in women who are or may become pregnant while receiving the drug and that the possibility exists that spontaneous abortion may occur if the drug is administered during pregnancy. However, while not FDA approved, leuprolide has been used in the treatment of infertility. The safety of this use has not been determined. Only the short-acting subcutaneous form of leuprolide should be used in the treatment of infertility.

Leuprolide Breastfeeding Warnings

There are no data on the excretion of leuprolide into human milk. While adverse effects in the nursing infant are unlikely due to destruction of the drug in the gastrointestinal tract, milk supply may be adversely affected. 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 benefit of breast-feeding to the infant and the importance of the drug to the mother.

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