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Naldemedine Pregnancy and Breastfeeding Warnings

Naldemedine is also known as: Symproic

Medically reviewed by Last updated on Mar 28, 2019.

Naldemedine Pregnancy Warnings

Animal studies have not shown adverse effects on embryofetal development. This drug does cross the placenta and may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. 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.

This drug should be used during pregnancy only if the benefit outweighs the potential risk to the fetus

US FDA pregnancy category: Not assigned

Risk Summary: There are no available data to inform a drug-associated risk of major birth defects and miscarriage.

Comment: There is a potential for opioid withdrawal in a fetus when this drug is used in pregnant women.

See references

Naldemedine Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother

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

-Breastfeeding is not recommended because of the potential for serious side effects in the breastfed infant, including opioid withdrawal.
-Women may resume breastfeeding 3 days after the final dose of this drug.

See references

References for pregnancy information

  1. "Product Information. Symproic (naldemedine)." Shionogi USA Inc, Florham Park, NJ.

References for breastfeeding information

  1. "Product Information. Symproic (naldemedine)." Shionogi USA Inc, Florham Park, NJ.

Further information

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