Is fetal exposure to azelaic acid cream 20 per cent harmful?/nA woman is pregnant in week 16. She h

Fråga: Is fetal exposure to azelaic acid cream 20 per cent harmful?

A woman is pregnant in week 16. She has been treated with azelaic acid cream (Skinoren) for acne since the beginning of pregnancy.

Sammanfattning: We have not found any information in the literature indicating an increased risk of congenital abnormalities when using therapeutic doses of topical azelaic acid during pregnancy.

Svar: This question has previously been dealt with in Drugline. No teratogenic or mutagenic effects have been seen during azelaic acid treatment in animal studies (1). An updated extensive literature search, including Medline, Drugline and communication with the manufacturer (2) has not revealed any reports on azelaic acid cream and teratogenicity (3-4). Plasma concentration of 0.038 mg/L was measured following topical application of 1.0 g of 20 per cent azelaic acid compared to 6 to 75 mg/L after single oral doses of 0.5 to 5 mg (5). Our most experienced expert on teratogenicity (6) is aware of 16 exposures during pregnancy to azelaic acid in the Swedish Birth Register. Only one malformation concerning hip instability was found among these births. Whether the malformation is related to the exposure is unknown.