Cabergoline Pregnancy and Breastfeeding Warnings

Cabergoline is also known as: Dostinex

Cabergoline Pregnancy Warnings

Cabergoline has been assigned to pregnancy category B by the FDA. Animal studies have revealed evidence of maternotoxicity (including an increased occurrence of various malformations), increase in postimplantation embryofetal losses, and inhibition of growth and death of offspring secondary to decreased milk secretion. There are no controlled data in human pregnancy. The drug should only be given during pregnancy when need has been clearly established.

The patient should be instructed to notify her physician if she suspects she is pregnant, becomes pregnant or intends to become pregnant during therapy. If there is any suspicion of pregnancy, a pregnancy test should be performed. One article which reviewed available data on 226 cabergoline-facilitated pregnancies in 205 women found the following. Twenty four miscarriages and three abortions induced because of major malformations (one Down syndrome in a 42 year old woman, one limb-body wall complex and one hydrocephalus) were reported. Two out of 148 single live-born infants had significant malformation (one megaureter and one scaphocephaly). The series of pregnancies showed no increase in the rate of miscarriages or congenital malformations. Follow up of 107 cases showed normal physical and mental development. In female rats, a dose of approximately 1/28th the maximum recommended human dose (on a body surface area basis) administered two weeks prior to mating and throughout the mating period was reported to inhibit conception. Whole body autoradiography studies in pregnant rats showed no fetal uptake but high levels in the uterine wall.

Cabergoline Breastfeeding Warnings

Whole body autoradiography studies in pregnant rats showed significant radioactivity (of the parent drug and metabolites) in the milk of lactating rats. This suggests there is a potential for exposure to nursing infants.

There are no data on the excretion of cabergoline into human milk. Because many drugs are excreted into human milk, and because of the potential for serious adverse reactions in nursing infants, 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. Additionally, the prolactin-lowering action of cabergoline suggests that it will interfere with lactation. Due to this interference with lactation, the drug should not be given to women postpartum who are breast-feeding or who are planning to breast-feed. Cabergoline is not recommended for the inhibition or suppression of physiologic lactation. (Use of bromocriptine, another dopamine agonist for this purpose, has been associated with hypertension, stroke and seizure.) Cabergoline is approved by the FDA for the treatment of patients with hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.

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