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Fluocinolone / hydroquinone / tretinoin topical Pregnancy and Breastfeeding Warnings

Fluocinolone / hydroquinone / tretinoin topical is also known as: Tri-Luma

Fluocinolone / hydroquinone / tretinoin topical Pregnancy Warnings

Fluocinolone-hydroquinone-tretinoin topical has been assigned to pregnancy category C by the FDA. Animal studies with topical fluocinolone-hydroquinone-retinoin have revealed evidence of an increase in number of still births, decrease in fetal weights, and teratogenicity. Oral tretinoin has been shown to be teratogenic and fetotoxic in high dose studies conducted in rats. Topical tretinoin was associated with fetal malformations and teratogenicity in some animal studies. There are no controlled data in human pregnancy for either tretinoin topical or fluocinolone-hydroquinone-tretinoin topical. However, there have been reports of possible teratogenicity related to topical tretinoin use during early pregnancy, including case reports of holoprosencephaly, ear malformation, limb reduction defects. Some experts suggest that topical tretinoin does not increase the risk of malformations, while others recommend avoiding its use during the first trimester or during the entire pregnancy. Fluocinolone-hydroquinone-tretinoin topical is only recommended for use during pregnancy when benefit outweighs risk.

In a dermal application study with fluocinolone-hydroquinone-tretinoin in pregnant rats there was evidence of a possible increase in the number of in utero deaths and a decrease in fetal weights in the litter. In a dermal application study of fluocinolone-hydroquinone-retinoin during organogenesis in pregnant rats there was evidence of possible teratogenicity similar to the type expected with tretinoin including cleft palate, protruding tongue, open eyes, umbilical hernia, and retinal folding or dysplasia. In a dermal application study in rats using a 10-fold dilution of fluocinolone-hydroquinone-retinoin, an increase in the number of stillborn pups, lower pup body weights, and delay in preputial separation was reported. There have been two reports of possible teratogenicity associated with topical tretinoin. In both cases, the mother had used tretinoin before conception and for several weeks during the first trimester. One baby was born with an ear malformation and the other had multiple congenital defects (including limb and heart abnormalities). A retrospective study of 215 women presumably exposed to topical tretinoin during the first trimester was conducted by Jick and colleagues. The occurrence of major anomalies among offspring of exposed women was 1.9% as opposed to 2.6% for those born to 430 age-matched nonexposed women. The authors concluded that topical tretinoin was not associated with an increased risk for major congenital disorders.

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Fluocinolone / hydroquinone / tretinoin topical Breastfeeding Warnings

There are no data on the excretion of topically applied fluocinolone-hydroquinone-tretinoin into human milk. The manufacturer recommends that caution be used when administering fluocinolone-hydroquinone-tretinoin topical to nursing women.

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References for pregnancy information

  1. Rothman KF, Pochi PE "Use of oral and topical agents for acne in pregnancy." J Am Acad Dermatol 19 (1988): 431-42
  2. Lipson AH, Collins F, Webster WS "Multiple congenital defects associated with maternal use of topical tretinoin." Lancet 341 (1993): 1352-3
  3. Manocha S, Walley KR, Russell JA "Severe acute respiratory distress syndrome (SARS): A critical care perspective." Crit Care Med 31 (2003): 2684-92
  4. Jick SS, Terris BZ, Jick H "First trimester topical tretinoin and congenital disorders." Lancet 341 (1993): 1181-2
  5. "Product Information. Tri-Luma (fluocinolone/hydroquinone/tretinoin topical)." Galderma Laboratories Inc, Fort Worth, TX.
  6. Camera G, Pregliasco P "Ear malformation in baby born to mother using tretinoin cream." Lancet 339 (1992): 687

References for breastfeeding information


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