Phytonadione Pregnancy and Breastfeeding Warnings

Brand names: Aquamephyton, Konakion, Mephyton, Vitamin K, Vitamin K1

Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.

Phytonadione Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: Not formally assigned to a pregnancy category.
US FDA pregnancy category: C (tablets); Not assigned (injectable solution)

Risk Summary: Published studies have not established a clear association between this drug and adverse maternal or fetal outcomes. In addition, these studies have not established the absence of any risk either.

Comments: Certain formulations of this drug contain benzyl alcohol. Preservative-free formulations are recommended if this drug is needed during pregnancy.

Animal studies have not been reported. 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.

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

Phytonadione Breastfeeding Warnings

Caution is recommended; benefit to mother should outweigh risk to the infant.

Excreted into human milk: Yes

Comments:
-Certain formulations of this drug contain benzyl alcohol. Preservative-free formulations are recommended if this drug is needed during lactation.
-Not recommended for nursing mothers as prophylaxis of newborn hemorrhagic disease.

The American Academy of Pediatrics classifies vitamin K1 as compatible with breastfeeding; they also caution that administration to the mother prenatally should not be substituted for newborn prophylaxis.

See references

Further information

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

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