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Tretinoin topical Pregnancy and Breastfeeding Warnings

Tretinoin topical is also known as: Altinac, Atralin, Avita, Obagi, Refissa, Renova, Retin A Micro, Retin-A, Retin-A and Renova, Retisol-A, Stieva-A, Stieva-A Forte, Tretin-X, Vitinoin

Tretinoin topical Pregnancy Warnings

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.

Topical tretinoin has been assigned to pregnancy category C by the FDA. 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. 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. Topical tretinoin is only recommended for use during pregnancy when benefit outweighs risk.

See references

Tretinoin topical Breastfeeding Warnings

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

See references

References for pregnancy information

  1. Krautheim A, Gollnick H "Transdermal penetration of topical drugs used in the treatment of acne." Clin Pharmacokinet 42 (2003): 1287-304
  2. Jick SS, Terris BZ, Jick H "First trimester topical tretinoin and congenital disorders." Lancet 341 (1993): 1181-2
  3. "Product Information. Retin-A (tretinoin)." Ortho Pharmaceutical Corporation, Raritan, NJ.
  4. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  5. Camera G, Pregliasco P "Ear malformation in baby born to mother using tretinoin cream." Lancet 339 (1992): 687
  6. Rothman KF, Pochi PE "Use of oral and topical agents for acne in pregnancy." J Am Acad Dermatol 19 (1988): 431-42
  7. Lipson AH, Collins F, Webster WS "Multiple congenital defects associated with maternal use of topical tretinoin." Lancet 341 (1993): 1352-3

References for breastfeeding information

  1. "Product Information. Retin-A (tretinoin)." Ortho Pharmaceutical Corporation, Raritan, NJ.

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