Formoterol Pregnancy and Breastfeeding Warnings

Brand names: Foradil Aerolizer, Perforomist

Medically reviewed by Drugs.com. Last updated on Jun 9, 2023.

Formoterol Pregnancy Warnings

Animal reproduction studies showed teratogenicity, including increased fetal malformations, decreased fetal weights, and increased neonatal mortality at oral doses approximately 730 to 29000 times the maximum recommended human dose (MRHD); no effects were seen with the inhalation route at 300 times the MRHD. Doses approximately 50 times the MRHD administered during organogenesis caused delayed ossification, and decreased fetal weight was seen at approximately 1500 times the MRHD. Animals given 1500 times the MRHD during late pregnancy had increased stillbirths and neonatal mortality, however no effects were seen at approximately 50 times the MRHD. 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.

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

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

Comment:
-Beta-agonists, including this drug, may potentially interfere with uterine contractility due to a relaxant effect on uterine smooth muscle; use during labor and delivery only if benefits outweigh risks.

See references

Formoterol Breastfeeding Warnings

Caution is recommended. Benefit should outweigh risk.

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

Comments:
-Women should contact their physician if they are nursing while taking the inhalation solution.
-The effects in the nursing infant and on milk production are unknown.
-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 on the child from the medication or the underlying maternal condition.

This drug and its metabolites was excreted in the breast milk of lactating rats given oral doses of 50 mcg/kg, and growth and survival of the pups were decreased when lactating rats were given oral doses greater than 1 mg/kg/day. A study in rats showed increased postnatal mortality at maternal oral doses of 0.2 mg/kg/day or greater, and retardation of pup growth at 15 mg/kg/day. The amount of drug found in animal milk was less than 2% of that in maternal plasma.

See references

Further information

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