Bromocriptine Pregnancy and Breastfeeding Warnings

Brand names: Cycloset, Parlodel

Medically reviewed by Drugs.com. Last updated on Mar 21, 2024.

Bromocriptine Pregnancy Warnings

Benefit should outweigh risk

AU TGA pregnancy category: A
US FDA pregnancy category: B

Comments:
-Fertility may be restored with this drug, therefore, women of childbearing age who do not wish to conceive should practice a reliable method of contraception.
-It is generally recommended that this drug be discontinued if pregnancy is suspected; however, continuation of therapy may be considered in the case of large pituitary tumors or signs of tumor expansion.

For Women Who Become Pregnant While on Therapy:
-Hyperprolactinemia: Stop therapy, if treatment is reinstituted for a rapidly expanding macroadenoma and a hypertensive disorder of pregnancy develops, the benefit of continued therapy should be assessed against the risks of use during a hypertensive disorder of pregnancy.
-Acromegaly, Prolactinoma, Parkinson's disease, or Diabetes mellitus: This drug should only be used if it is deemed medically necessary, if it is continued, it should be stopped if a hypertensive disorder of pregnancy develops unless withdrawal is medically contraindicated.

Studies in pregnant women have not shown an increased risk of abnormalities. Among 1276 pregnancies there were 1088 full-term deliveries (4 stillborn), 145 spontaneous abortions (11.4%), 28 induced abortions (2.2%) and 12 extrauterine gravidities and 3 hydatidiform moles (twice in the same patient) caused early termination of pregnancy. For most women this drug had been discontinued within 8 weeks of pregnancy; 8 patients treated throughout pregnancy received a mean daily dose of 5.8 mg [range: 1 to 40 mg]). A review of 2351 pregnancies from 4 different multicenter surveillance programs looked at 2185 women who received this drug during pregnancy. This review showed that 75% or more had taken this drug for 2 to 8 weeks at doses of 5 to 10 mg/day; no adverse effects on the post-natal development were found for the 583 babies who were followed for 3 to 12 months; 1 spontaneous abortion was reported among 86 women (93 pregnancies) receiving this drug throughout pregnancy or from week 30 onwards. Evidence suggests a lack of teratogenic or embryopathic effects in humans and therefore, treatment with this drug may be considered for a large tumor or evidence of expansion. If used during pregnancy, it should be discontinued if a hypertensive disorder of pregnancy develops. There are no controlled data in human pregnancy.

This drug should not be used during the postpartum period in women with a history of coronary artery disease or other severe cardiovascular conditions unless withdrawal is considered medically contraindicated. If the drug is used in the postpartum period, the patient should be observed with caution.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Bromocriptine Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug

Excreted into human milk: Undetectable

Comments:
-This drug inhibits lactation; this drug is no longer indicated for inhibition of postpartum lactation in the US because of postmarketing reports of serious and sometimes fatal cardiovascular events including stroke and myocardial infarction; in those countries where this drug continues to be used to suppress lactation, cerebral angiopathy, stroke, and seizures, continue to be reported.
-This drug should be considered contraindicated for use during the postpartum period in women with a history of coronary artery disease and other severe cardiovascular conditions unless withdrawal is considered medically contraindicated; if used, close monitoring is advised.

This drug is generally not used during breastfeeding because it suppresses lactation. An indication for postpartum breast engorgement was withdrawn in the US in 1994 because of postmarketing reports of serious maternal toxicity, including stroke, convulsions, myocardial infarction, and severe hypertension. In 14 women receiving 2.5 mg once a day for 3 days, drug levels were undetectable (less than 0.2 mcg/L). Among an unspecified number of women who received this drug immediately postpartum, the composition of their breastmilk was altered in that most protein constituents appeared in higher concentrations than normal, similar to those of colostrum. Lactose levels were also suppressed.

See references

Further information

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