Clobetasol topical Pregnancy and Breastfeeding Warnings
Clobetasol topical is also known as: Clobevate, Clobex, Clodan, Cormax, Cormax Scalp, Dermovate, Embeline, Embeline E, Impoyz, Olux, Olux-E, Olux/Olux-E Kit, Temovate, Temovate E, Temovate Emollient
Medically reviewed by Drugs.com. Last updated on Apr 16, 2019.
Clobetasol topical Pregnancy Warnings
Use should be avoided, unless clearly necessary.
AU TGA pregnancy category: B3
US FDA pregnancy category: C
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.
Animal studies have revealed evidence of teratogenicity after corticosteroids were administered orally or potent steroids were applied topically. This drug has been shown to be teratogenic when administered topically or subcutaneously to mice, rats and rabbits. There are no controlled data in human pregnancy.
Clobetasol topical Breastfeeding Warnings
Studies in rats have revealed postnatal pup effects following subcutaneous maternal dosing during weaning. Topical corticosteroids should be wiped off thoroughly prior to breastfeeding if they are being applied to the breast or nipple area. Clobetasol should be avoided on the nipple.
Use should be avoided, unless clearly necessary.
Excreted into human milk: Data not available
Excreted into animal milk: Yes
Comments: The effects in the nursing infant are unknown.
References for pregnancy information
- "Product Information. Temovate (clobetasol)." Glaxo Wellcome, Research Triangle Park, NC.
- Cerner Multum, Inc. "Australian Product Information." O 0
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
References for breastfeeding information
- "Product Information. Temovate (clobetasol)." Glaxo Wellcome, Research Triangle Park, NC.
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
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Further information
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