Benefit should outweigh risk

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

Risk Summary: There are no published studies showing increases in congenital malformations or other adverse perinatal outcome with inhaled corticosteroids (ICS); available human data do not establish the presence or absence of drug-associated risk to the fetus.

Comments: There are risks associated with inadequate asthma control during pregnancy; the level of asthma control should be closely monitored.

Systemic administration of relatively high doses in animals has shown abnormalities of fetal development including growth retardation and cleft palate. In rats exposed to inhaled doses, fetal adrenal injury was observed at dose greater than 180 times the maximum recommended human daily inhalation dose (MRHDID), while no evidence of external or skeletal malformations or embryolethality was observed at doses up to 440 times MRHDID. Epidemiologic data, including studies of large birth registries, have not shown inhaled corticosteroids (ICS) to increase congenital malformations or other adverse perinatal outcomes. Epidemiologic data is lacking on the oral administration of this drug. There are no adequate and well controlled studies in pregnant women.

Clinical considerations: Poorly controlled or inadequately controlled asthma has been associated with an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.

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

Most experts consider inhaled corticosteroids acceptable during breastfeeding as the presence in breastmilk is expected to be low and infant exposure negligible. No studies have specifically described the presence of this drug in animal milk or breast milk; however, it is reasonable to assume it is excreted in milk. Due to lack of specific data, benefits to the mother should be weighed against any potential risk to the breastfed infant.

Benefit should outweigh risk

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

Comment: At therapeutic doses minimal effects are expected with inhaled drug.

See references