Flunisolide Pregnancy and Breastfeeding Warnings

Brand names: Aerobid, Aerobid-M, Aerospan HFA

Flunisolide Pregnancy Warnings

Use is not recommended unless the benefit outweighs the risk to the fetus

US FDA pregnancy category: Not assigned

Comments:
-Asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control in pregnant women.
-Infants exposed to corticosteroids in utero should be observed for signs and symptoms of hypoadrenalism.

Animal studies in rats and rabbits have shown teratogenicity and fetotoxicity, including fetal structural abnormalities when given during organogenesis, in doses approximately 1 and 3 times the maximum recommended daily inhalation dose (on a mg/m2 basis), respectively. Experience with pharmacologic doses of oral corticosteroids suggests rodents may be more prone to teratogenic effects than humans. There are no adequate and well-controlled studies in pregnant women.

In a review of 229,101 deliveries to Michigan Medicaid patients, 141 first-trimester exposures to flunisolide and 322 exposures anytime during pregnancy were recorded. A total of 5 birth defects were reported with first-trimester exposures (5 expected). (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) These data do not support an association with adverse fetal outcome.

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.
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Flunisolide Breastfeeding Warnings

Caution is recommended.

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

Comments:
-There is no information on the presence of this drug in human milk, or its effects on the breastfed child or milk production.
-Inhaled corticosteroids are generally considered acceptable to use during breastfeeding as the amount, if excreted into breastmilk, would probably be too small to affect a breastfed infant.
-Consider the developmental and health benefits of breastfeeding and the mother's clinical need for this drug as well as any potential adverse effects on the breastfed infant from the use of this drug or from the mother's underlying condition.

See references

Further information

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

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