Oxistat Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
US FDA pregnancy category: B
Animal studies have failed to reveal evidence of fetal harm; rabbits, rats, and mice were administered oral doses up to 100, 150, and 200 mg/kg/day (57, 40, and 27 times the human dose based on mg/m2), respectively. There are no controlled data in human pregnancy.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
See references
Oxistat Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Yes
Comments:
-The effects in the nursing infant are unknown; low risk is expected (less than 1% absorbed after topical use).
-Application to the nipple area should be avoided; the infant's skin should not come into direct contact with skin that has been treated.
See references
