Vamorolone Pregnancy and Breastfeeding Warnings

Brand names: Agamree

Vamorolone Pregnancy Warnings

Benefit should outweigh risk.

US FDA pregnancy category: Not assigned

Risk summary: Based on the effects of corticosteroids in pregnant patients and animals, this drug can cause adverse developmental outcomes when administered to a pregnant woman.

Comments:
-There are no data available on use of this drug in pregnant women to inform a drug-related risk.
-Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Animal studies have not been reported with this drug; however, animal studies conducted with other corticosteroids at clinically relevant doses have shown an increased incidence of cleft palate. In some animal species, an increase in embryofetal death, intrauterine growth retardation, and constriction of the ductus arteriosus was observed.

In humans, epidemiologic studies report an increased rate of orofacial clefts (with or without cleft palate) from about 1 per 1000 infants to 3 to 5 per 1000 infants that was associated with maternal corticosteroid use during the first trimester. Other studies have shown dose-related occurrences of decreased birth weight and intrauterine growth restriction in infants exposed to maternal corticosteroids in utero. However, the underlying maternal condition may also contribute to these risks in infants. 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

Vamorolone Breastfeeding Warnings

Safety has not been established.
-According to some authorities: Breastfeeding should be discontinued during treatment.

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

Comments:
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-A risk to the breastfed infant cannot be excluded; systemic corticosteroids are excreted in breast milk and may suppress growth, interfere with endogenous corticosteroid production, or cause other adverse effects.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects on the breastfed infant.

See references

Further information

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