Bromocriptine Pregnancy and Breastfeeding Warnings
Bromocriptine Pregnancy Warnings
Bromocriptine has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of embryotoxicity, fetotoxicity, and teratogenicity. There are no controlled data in human pregnancy. The safety of bromocriptine administration during pregnancy has not been established. Bromocriptine is only recommended for use during pregnancy when benefit outweighs risk.
Postmarketing data were collected in 1276 pregnancies. Although in the majority of the cases bromocriptine therapy was discontinued within 8 weeks of pregnancy, 8 patients received a mean daily dose of 5.8 mg (range 1 mg to 40 mg) continuously throughout pregnancy. Of the 1276 pregnancies, there were 1088 full-term deliveries (4 stillborn), 145 spontaneous abortions (11.4%), and 28 induced abortions (2.2%). In addition, 12 extrauterine gravidities and 3 hydatidiform moles (twice in the same patient) caused early termination of pregnancy. In spite of these case results, no correlation has been established between the use of bromocriptine and birth defects. A 29-year-old Japanese woman gave birth to a normal healthy male baby weighing 2.98 Kg after bromocriptine treatment throughout the 34th week of gestation. Bromocriptine 5 mg orally daily was initiated after failing other drug therapies used for the treatment of a microadenoma in the anterior pituitary lobe that affected her ability to conceive. Four-weeks after the start of therapy with bromocriptine, the patient began to have regular menstrual cycles and became pregnant.
Bromocriptine Breastfeeding Warnings
There are no data on the excretion of bromocriptine into human milk. Because bromocriptine suppresses lactation, bromocriptine is considered to be contraindicated during breast-feeding by the American Academy of Pediatrics.
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