Birch triterpenes topical Pregnancy and Breastfeeding Warnings

Brand names: Filsuvez

Birch triterpenes topical Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not Assigned

Comments:
-There are no available data with use of this drug in pregnant women to evaluate for drug associated risk factors of major defects, miscarriage or adverse maternal or fetal outcomes.
-Systemic absorption of this drug is low following topical administration, and maternal use is not expected to result in fetal exposure to the drug.

Animal reproduction studies reported no maternal toxicity or fetal malformations when this drug was administered orally at doses up to 100 mg/kg/day. However, the available data do not support relevant comparisons of systemic exposures achieved in animal studies to exposures observed in humans after topical use. 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

Birch triterpenes topical Breastfeeding Warnings

Benefit should outweigh risk.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-No effects on the breastfed infant are anticipated since the systemic exposure would be low.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

Further information

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