Skinoren Gel Use In Pregnancy & Lactation

Pregnancy: There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women.
Animal studies do indicate the potential for effects with respect to pregnancy, embryo-fetal development, parturition or postnatal development. However, the dose levels without observed adverse effects in animals ranged across studies from 3-32 times the maximum recommended human dose based on body surface area.
Caution should be exercised when prescribing azelaic acid to pregnant women.
Lactation: It is not known if azelaic acid is secreted into human milk in vivo. However an in vitro equilibrium dialysis experiment demonstrated that passage of drug into maternal milk may occur. But the distribution of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk since azelaic acid is not concentrated in milk and systemic uptake of topically applied azelaic acid did not increase endogenous azelaic acid exposure above physiological levels.
However, caution should be exercised when Azelaic acid (Skinoren) gel is administered to a nursing woman.