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Arformoterol Pregnancy and Breastfeeding Warnings

Arformoterol is also known as: Brovana

Medically reviewed by Drugs.com. Last updated on Jun 6, 2019.

Arformoterol Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Advise patients to notify their healthcare provider if they become pregnant while on this drug.
-Beta agonists may interfere with uterine contractility; use this drug during labor only if the benefit clearly outweighs the risk.

Animal studies showed teratogenicity (umbilical hernia) at about 370 the maximum recommended human daily inhalation dose (MRHDID); doses up to 2400 times the MRHDID did not show maternal toxicity; at doses about 8400 times the MRHDID showed teratogenicity (malpositioned right kidney): doses up to 26,000 times the MRHDID showed brachydactyly, bulbous aorta, liver cysts, and decreased fetal weight. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

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

Arformoterol Breastfeeding Warnings

Animal studies showed this drug and its metabolites in rat milk after oral administration of 10,000 mcg/kg.

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available
Excreted into animal milk: Yes

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

References for pregnancy information

  1. "Product Information. Brovana (arformoterol)." Sepracor Inc, Marlborough, MA.

References for breastfeeding information

  1. "Product Information. Brovana (arformoterol)." Sepracor Inc, Marlborough, MA.

Further information

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

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