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Clobetasol topical Pregnancy and Breastfeeding Warnings

Clobetasol topical is also known as: Clobevate, Clobex, Clodan, Cormax, Cormax Scalp, Dermovate, Embeline, Embeline E, Impeklo, Impoyz, Olux, Olux-E, Olux/Olux-E Kit, Temovate, Temovate E, Temovate Emollient, Tovet

Medically reviewed by Drugs.com. Last updated on Nov 12, 2021.

Clobetasol topical Pregnancy Warnings

Use should be avoided, unless clearly necessary.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks.
-Systemic corticosteroids are teratogenic in animal models at relatively low doses; some have shown teratogenicity after topical administration.
-Topical application of this drug has not been studied for teratogenicity, but it is absorbed percutaneously.
-This drug has greater teratogenic potential than less potent steroids.

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.


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 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

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:
-Systemically administered corticosteroids appear in human milk and may suppress growth, affect endogenous corticosteroid production, or cause other adverse effects.
-It is unknown if topical corticosteroid administration is sufficiently absorbed to be excreted in breast milk.

See references

References for pregnancy information

  1. "Product Information. Temovate (clobetasol)." Glaxo Wellcome, Research Triangle Park, NC.
  2. "Product Information. Clobetasol Propionate (clobetasol topical)." Encube Ethicals, Inc., Durham, NC.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Clobetasol Propionate (clobetasol topical)." Encube Ethicals, Inc., Durham, NC.
  2. "Product Information. Temovate (clobetasol)." Glaxo Wellcome, Research Triangle Park, NC.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.