Mirabegron Pregnancy and Breastfeeding Warnings

Mirabegron is also known as: Myrbetriq

Medically reviewed on Sep 11, 2017

Mirabegron Pregnancy Warnings

Benefit should outweigh risk

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: There are no studies in pregnant women to inform a a drug-associated risk for birth defects or miscarriages. Animal data suggest a low probability of direct or indirect harmful effects at therapeutic doses.

Comments:
-Some authorities suggest as a precautionary measure, it is preferable to avoid use in women of childbearing potential unless effective contraception measures are being used.

In animals, embryofetal toxicities, including heart malformations (dilated aorta cardiomegaly), pulmonary malformations, postimplantation loss, wavy ribs, delayed ossification, and decreased number of ossified sternebrae, metacarpi or metatarsi, have been reported at doses associated with maternal toxicity and significantly higher than would be expected in humans. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Mirabegron Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: There is no information on the effects on the breastfed child or the effects on milk production.

Pharmacokinetic studies with radiolabeled drug have shown parent drug and/or metabolites are excreted into rat milk at levels approximately 1.7-fold higher than plasma levels at 4-hours post dose.

See references

Further information

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