Deflazacort Pregnancy and Breastfeeding Warnings

Brand names: Emflaza

Medically reviewed by Drugs.com. Last updated on Jul 10, 2023.

Deflazacort Pregnancy Warnings

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

AU TGA pregnancy category: Not formally assigned to a pregnancy category
US FDA pregnancy category: Not assigned

Risk summary: Inadequate data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Infants exposed to higher doses of corticosteroids in utero should be carefully observed for signs of hypoadrenalism.

Animal studies have not been reported. Corticosteroids (including this drug) readily cross the placenta. Adverse developmental outcomes (including orofacial clefts [cleft lip, with or without cleft palate], intrauterine growth restriction) and decreased birth weight have occurred with maternal use of corticosteroids (including this drug) during pregnancy. There are no controlled data in human pregnancy.
-Animal studies with other corticosteroids have revealed evidence of teratogenicity, embryofetal toxicity, and embryofetal lethality. At clinically relevant doses, an increased incidence of cleft palate was observed in mice, rats, hamsters, and rabbits; in some animal species, an increase in embryofetal death, intrauterine growth retardation, and constriction of the ductus arteriosus were seen. A number of cohort and case-controlled studies in humans suggest maternal corticosteroid use in the first trimester increases the rate of cleft lip (with or without cleft palate) from about 1 per 1000 infants to 3 to 5 per 1000 infants. In 2 prospective case-controlled studies, decreased birth weight was observed in infants exposed to maternal corticosteroids in utero. Intrauterine growth restriction and decreased birth weight appear to be dose-related; however, the underlying maternal condition may also contribute to these risks. There are no controlled data in human pregnancy.

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

Deflazacort Breastfeeding Warnings

An alternate corticosteroid may be preferred, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: Benefit should outweigh risk.

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

Comments:
-No information is available on the use of this drug during breastfeeding.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug and any potential side effects in the breastfed child due to this drug.
-Systemic corticosteroids are excreted into human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects.
-No effects in breastfed infants have been reported with any corticosteroid.

Corticosteroids have been detected in breast milk; however, no data are available for this drug.

Doses of up to 50 mg/day of this drug are unlikely to cause systemic effects in the infant. Infants of mothers taking doses higher than 50 mg/day may have a degree of adrenal suppression, but the benefits of nursing are likely to outweigh any theoretical risk.

See references

Further information

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