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Fluocinonide topical Pregnancy and Breastfeeding Warnings

Fluocinonide topical is also known as: Dermacin, Fluex, Fluocinonide-E, Licon, Lidex, Lidex-E, Vanos

Fluocinonide topical Pregnancy Warnings

Fluocinonide has been assigned to pregnancy category C by the FDA. Animals studied have revealed evidence of teratogenicity when corticosteroids are administered orally. There are no controlled data in human pregnancy. Fluocinonide is only recommended for use during pregnancy when benefit outweighs risk.

In a review of 229,101 deliveries to Michigan Medicaid patients during 1985 to 1992, 313 first-trimester exposures to fluocinonide were recorded and 836 exposures anytime during pregnancy. A total of five birth defects were reported with first trimester exposure (12 expected) and included (observed/expected) 3/3 cardiovascular defects and 1 case each of polydactyly, spina bifida, and limb reduction. When administered anytime during pregnancy nine brain birth defects were reported (four expected). Brain defects may include congenital hydrocephalus, microcephaly, brain reduction, or encephalocele. This represents a significant relative risk for brain defects. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)

Fluocinonide topical Breastfeeding Warnings

There are no data on the excretion of topically applied fluocinonide into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be make to discontinue nursing or discontinue the drug, taking into consideration to the mother.

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