Corticotropin Pregnancy and Breastfeeding Warnings

Brand names: ACTH, Acthar, H.P. Acthar Gel

Medically reviewed by Drugs.com. Last updated on Nov 19, 2024.

Corticotropin Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk summary: This drug may cause fetal harm when administered to a pregnant woman. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments: Women should be apprised of the potential harm to the fetus.

This drug has been shown to have embryocidal effects. Published data on systemic corticosteroids suggest potential risks, including intrauterine growth restriction, decreased birth weight, and preterm birth. 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.

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Corticotropin Breastfeeding Warnings

Benefit should outweigh risk

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

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-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 to the breastfed infant from the drug or from the underlying maternal condition.

This drug is unlikely to be excreted into breast milk because of its molecular weight (4540) and short half-life (10 to 15 minutes). If excreted, absorption is unlikely because it would probably be destroyed in infant's gastrointestinal tract. Animal data suggests maternal use of this drug may increase breast milk cortisol levels. The manufacturer recommends a decision be made whether to discontinue nursing or to discontinue the drug considering the risks and benefits to the mother.

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Further information

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