Sklice Pregnancy Warnings
This drug should be used only if the potential benefit potential benefit justifies the potential risk to the fetus.
-According to some authorities: Use is not recommended.
AU TGA pregnancy category: B3
US FDA pregnancy category: C (1% cream)
US FDA pregnancy category: Not assigned (0.5% lotion)
Risk Summary (0.5% lotion): No data available on use of this drug in pregnant women to inform a drug-related risk.
Animal studies with the topical formulations have not been conducted. Oral reproductive toxicity studies have shown evidence of teratogenicity in animals. There are no controlled data in human pregnancy.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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
Sklice Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Systemic exposure is much lower than that for the oral formulation.
-Avoid application to the breast area where the infant may directly ingest this drug.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-Potential side effects in the breastfed child due to the drug or the mother's underlying condition should be considered.
See references
