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Betamethasone topical Pregnancy and Breastfeeding Warnings

Betamethasone topical is also known as: Alphatrex, Beta-Val, Betacort, Betaderm, Betamethacot, Betanate, Betatrex, Betnovate, Del-Beta, Diprolene, Diprolene AF, Diprosone, Luxiq, Maxivate, Sernivo, Teladar, Uticort, Valisone

Medically reviewed by Last updated on Oct 13, 2018.

Betamethasone topical Pregnancy Warnings

Intramuscular doses administered to rabbits have been shown to be teratogenic with abnormalities including umbilical hernias, cephalocele, and cleft palate. Animal studies have shown the more potent corticosteroids to be teratogenic after dermal application. There are no adequate and well-controlled studies in pregnant women.

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.

Benefit should outweigh risk

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments: Topical corticosteroids should not be used extensively on pregnant patients, in large amounts or for extended periods of time.

See references

Betamethasone topical Breastfeeding Warnings

Corticosteroids appear in human milk when administered systemically and can suppress growth and interfere with endogenous corticosteroid production. The safety of topical corticosteroids during lactation has not been established as it is not known whether topical administration can result in sufficient systemic absorption to produce detectable quantities in human milk. If used, only water-miscible cream should be applied to the areas the infant may be able to lick as ointments may expose infants to high levels of mineral paraffins via licking.

Benefit should outweigh risk

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

-Systemic effects are not likely to occur with short-term topical application; however, if a topical corticosteroid is needed, it would be prudent to use a low-potency corticosteroid on the smallest skin area possible.
-Topical administration should be avoided on the nipple or any area where the infant could directly ingest the drug from the skin.

See references

References for pregnancy information

  1. Petersen MC, Nation RL, Ashley JJ, McBride WG "The placental transfer of betamethasone." Eur J Clin Pharmacol 18 (1980): 245-7
  2. "Product Information. Diprolene (betamethasone topical)." Schering Laboratories, Kenilworth, NJ.
  3. Anderson AB, Gennser G, Jeremy JY, Ohrlander S, Sayers L, Turnbull AC "Placental transfer and metabolism of betamethasone in human pregnancy." Obstet Gynecol 49 (1977): 471-4

References for breastfeeding information

  1. "Product Information. Diprolene (betamethasone topical)." Schering Laboratories, Kenilworth, NJ.

Further information

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