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Mirabegron Pregnancy and Breastfeeding Warnings

Mirabegron is also known as: Myrbetriq

Mirabegron Pregnancy Warnings

Use is not recommended in women of childbearing potential not using contraception unless the potential benefit to the patient outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments:
-Women who become pregnant during treatment with this drug are encouraged to contact their physician.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Mirabegron Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Myrbetriq (mirabegron)." Astellas Pharma US, Inc, Deerfield, IL.
  3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

References for breastfeeding information

  1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  2. "Product Information. Myrbetriq (mirabegron)." Astellas Pharma US, Inc, Deerfield, IL.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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