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Aducanumab Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Jun 18, 2021.

Aducanumab is also known as: Aduhelm

Aducanumab Pregnancy Warnings

Safety has not been established during pregnancy

US FDA pregnancy category: Not assigned

Risk summary: There are no adequate data on use of this drug in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Animal studies in pregnant rats have not shown adverse effects on embryofetal development or adverse effects on pre or postnatal development. The relevance of these findings to humans may be limited because aggregated amyloid beta is not present in rats. 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

Aducanumab Breastfeeding Warnings

Benefit should outweigh risk

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

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. Aduhelm (aducanumab)." Biogen Idec Inc (2021):

References for breastfeeding information

  1. "Product Information. Aduhelm (aducanumab)." Biogen Idec Inc (2021):

Further information

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