Tretinoin

Pregnancy

While there are no adequate and well-controlled studies in pregnant women, animal studies showed that oral and topical tretinoin can cause serious birth defects.

Tretinoin negatively affected fetal growth and development in rats when given orally or topically in doses 8 times the maximum adjusted human oral dose.

When tretinoin was used orally (not topically) in the cynomolgus monkey, which is an animal species that is metabolically closer to humans, fetal malformations were reported at doses 83 times the maximum adjusted human oral dose, but not at 41.5 times the maximum adjusted human oral dose. Increased skeletal variations were observed at all doses.

Over two decades of clinical use of tretinoin, 30 human cases of malformations in newborns affecting the brain have been reported. While no definitive pattern or causal relationship has been confirmed, 5 of these cases involved the rare birth defect category of holoprosencephaly, characterized by incomplete midline development of the forebrain. The significance of these human case reports in terms of risk to the fetus is not known.

Be sure to talk to your doctor before using tretinoin when pregnant or planning to become pregnant.

>> More on How to Treat Acne During Pregnancy

Breastfeeding

It is not known whether tretinoin is excreted in human milk. Because many drugs are excreted in human milk, a woman and her doctor should decide whether to discontinue nursing before using tretinoin, taking into account the importance of the drug use to the mother.

Furthermore, do not apply tretinoin to the nipple area, and make sure the infant’s skin does not come into contact with the areas of skin that have been treated with tretinoin. Make sure to wash your hands after the application of tretinoin.