Science to Practice
Latest highlights on drug safety and efficacy

18.2.2026

Due to high risk of teratogenicity, systemic use of retinoids is strictly forbidden for women of reproductive potential not using efficient method(s) of contraception. There are specific measures to prevent inadvertent pregnancies, like regular monthly pregnancy tests for the users of systemic isotretinoin, and limiting the right to prescribe of isotretinoin to only dermatologists, and restricting the length of validity for prescriptions.

Based on teratogenicity of isotretinoin, also the use of topical retinoids like adapalene for the treatment of acne should be avoided in women of childbearing potential. Large-scale, population-based data on the use of topical retinoids has been lacking, however.

A large Nordic cohort study finds no increased risk of major congenital malformations with first-trimester exposure to topical retinoids – although precautionary use in pregnancy remains justified.

In a recent population-based cohort study from Denmark, Iceland, Norway, and Sweden, use of topical retinoids increased over 3-fold over the 18-year study period (2006-2024). Of the almost 3.9 million infants included in the cohort, 0.86 per 1000 were exposed to topical retinoids during the first trimester. There was no increase in risk for major congenital malformations when comparing the exposed to unexposed, or to infants exposed to azelaic acid or clindamycin. Among the 2172 infants exposed to topical retinoids, 71 had any major congenital malformation (3.3%) (1).

There are important limitations in the study, however. Most importantly, there is a possibility of underestimation of the frequency of use and the risk of congenital malformations due to exclusion of pregnancies that ended before 22 weeks of gestation. The authors concluded that a safety precaution for use in pregnancy is still justified, but findings of the study could provide reassurance for women who become pregnant while using topical retinoids (1).

For more comprehensive information, explore Gravbase and Lactbase, our specialised databases providing detailed insights on drug safety and efficacy during pregnancy and lactation.

News produced by Medbase Medical Team

References

1. Refsum E, Furu K, Cesta CE, Nørgaard M, Wittström F, Zoega H, Ulrichsen SP, Cohen JM. Topical retinoid use in women of reproductive age and risk of major congenital malformations in exposed pregnancies – a Nordic cohort study. Br J Dermatol. 2025 Dec.