Acthar gel, h.p. 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
Acthar gel, h.p. 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
