Retacnyl Use In Pregnancy & Lactation

Pregnancy: Studies in animal have shown that oral tretinoin is fetotoxic in rats given 500 times the topical human dose and teratogenic in rats given 1,000 times the topical human dose. Topical tretinoin has caused delayed ossification in a number of bones in the offspring of rats and rabbits given 100 to 320 times the topical human dose, respectively. There has been increasing incidence of foetal malformation following topical administration of tretinoin. Orally administered retinoids have been associated with congenital abnormalities. Use of topical tretinoin is not recommended during pregnancy, especially in the first trimester. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result in low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure. Retacnyl cream is contraindicated in pregnancy, or in women planning a pregnancy. If the product is used during pregnancy, or if the patient becomes pregnant while using this drug, treatment should be discontinued.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.