Naftifine topical Pregnancy and Breastfeeding Warnings

Brand names: Naftin, Naftin-MP

Medically reviewed by Drugs.com. Last updated on May 26, 2023.

Naftifine topical Pregnancy Warnings

Animal studies have failed to reveal evidence of embryofetal toxicity or teratogenicity. 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.

Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

See references

Naftifine topical Breastfeeding Warnings

Caution is recommended.

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

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-This drug has not been studied during breastfeeding; application to the nipple area should be avoided.
-Maternal use is considered a low risk to the nursing infant since only 4% to 6% is absorbed after topical application.
-The infant's skin should not come into direct contact with skin that has been treated.

See references

Further information

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