Formoterol / glycopyrrolate Pregnancy and Breastfeeding Warnings

Brand names: Bevespi Aerosphere

Medically reviewed by Drugs.com. Last updated on Nov 14, 2023.

Formoterol / glycopyrrolate Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-There is no adequate and well controlled data on use of this drug or its components individually in pregnant women to know this drugs risks.
-Animal studies of glycopyrrolate alone, subcutaneously, did not cause structural abnormalities or affect fetal survival at doses up to 5400 times the maximum recommended human daily inhalation dose (MRHDID).
-Animal studies of formoterol alone, orally, caused structural abnormalities at 1500 to 61,000 times the MRHDID, and was embryocidal, increased pup loss at birth and lactation, and decreased pup weight at 110 times MRHDID; these effects ere seen at large MRHDID multiples when given to achieve high systemic exposures.
-Animal studies of formoterol alone by inhalation showed no structural abnormalities, embryocidal, or developmental effects at up to 350 times the MRHDID.
-This drug should be used during labor only if the potential benefit justifies the potential risk.

Animal studies are not available for the combination product. 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%.

Formoterol fumarate: This drug has been shown to be teratogenic, embryocidal, to increase pup loss at birth and during lactation, and to decrease pup weights in rats and teratogenic in rabbits at oral doses up to 1500 times the maximum recommended human daily inhalation dose (MRHDID). Umbilical hernia, prolonged pregnancy and fetal brachygnathia, and subcapsular cysts on the liver were observed in rats and rabbits at doses about 8000 times the MRHDID. No structural abnormalities, embryocidal or developmental effects were seen at 350 time the MRHDID in embryofetal studies.

Glycopyrrolate: There was no evidence of teratogenic effects in rats and rabbits at doses up to 2700 times the MRHDID. Fetal body weights were unaffected at up to 270 times the MRHDID; maternal toxicity was seen at 270 times the MRHDID and higher.


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

Formoterol / glycopyrrolate Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available (formoterol-glycopyrrolate)
Excreted into animal milk: Yes (formoterol-glycopyrrolate)

Comments:
-There is no information regarding this drug on the presence in human milk or the effects on a breastfed infant.
-Both drug components have been detected in undosed rat pups suckling from exposed dams.
-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

Further information

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