Peanut allergen powder Pregnancy and Breastfeeding Warnings

Brand names: Palforzia

Medically reviewed by Drugs.com. Last updated on Feb 9, 2024.

Peanut allergen powder Pregnancy Warnings

Safety has not been established during pregnancy.
According to some authorities: Use is not recommended.

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.

Comments:
-A pregnancy exposure registry is available.
-This drug may cause anaphylaxis.
-Anaphylaxis may occur from accidental peanut exposure in peanut-allergic patients.
-Anaphylaxis may cause dangerous hypotension, which may compromise placental perfusion, causing significant risk to the fetus.

Animal studies have not been reported. There are no controlled data in human pregnancy.

The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

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

Peanut allergen powder Breastfeeding Warnings

Benefit to mother should outweigh risk to the infant.

Excreted into human milk: Yes

Comments:
-The peanut protein allergens Ara h1, 2 and 6 have been detected in breastmilk.
-The effects in the nursing infant or the effects on milk production are unknown.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this drug as well as any potential adverse effects from this drug or the underlying maternal condition.

A more recent subpopulation analysis of a controlled study found that if mothers consume less than 5 grams per week of peanuts while breastfeeding, it may reduce peanut sensitization and allergy in high-risk infants at 5 years of age.

See references

Further information

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