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Corticotropin Pregnancy and Breastfeeding Warnings

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

Medically reviewed by Drugs.com. Last updated on Aug 16, 2023.

Corticotropin Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: C

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

This drug has been shown to have embryocidal effects. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Corticotropin Breastfeeding Warnings

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.

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.

See references

References for pregnancy information

  1. Product Information. Acthar Gel, H.P. (corticotropin). Questcor Pharmaceuticals Inc. 2019.

References for breastfeeding information

  1. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
  2. Product Information. Acthar Gel, H.P. (corticotropin). Questcor Pharmaceuticals Inc. 2019.

Further information

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