Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

There are no adequate data from the use of topically applied tretinoin in women. Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result into 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.

Animal studies with topically applied RET-AVIT did not show any toxicity to reproduction (see section 5.3), although literature data indicate that high doses of topically applied tretinoin may be fetotoxic.

Pregnancy
RET-AVIT is contraindicated (see section 4.3) in pregnancy, or in women planning a pregnancy.
If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.

Breast-feeding
It is not known whether tretinoin is secreted in breast milk. Caution should be exercised when RET-AVIT is administered to breastfeeding mothers.