A MAJOR Nordic study has found no evidence of an increased risk of major congenital malformations in infants exposed to topical retinoids during early pregnancy, offering some reassurance for women who may inadvertently use these acne treatments before realising they are pregnant.
Topical retinoids, commonly prescribed for mild to moderate acne, are widely avoided in pregnancy because of the known teratogenic effects of oral isotretinoin, a systemic retinoid associated with severe birth defects. However, topical retinoids are absorbed into the body at much lower levels than oral isotretinoin, and evidence on their safety in pregnancy has been limited. As a result, current guidance generally advises caution or avoidance during pregnancy.
Trends in Topical Retinoid Use Among Women of Reproductive Age
The new study examined nationwide health and prescription registries across Denmark, Iceland, Norway and Sweden. Researchers first analysed trends in topical retinoid use among women aged 15 to 44 between 2006 and 2024. They found that use has risen markedly, increasing more than threefold, from 8.7 per 1,000 women in 2006 to 28.5 per 1,000 in 2024. The authors suggest this rise may reflect broader access to dermatological treatments and increased awareness of acne management.
The team then evaluated pregnancy exposures using data from 3.87 million births across the four countries between 1996 and 2020. Only a small proportion of infants, 0.86 per 1,000, had confirmed first-trimester exposure to topical retinoids. Among these exposed infants, 3.3% were diagnosed with a major congenital malformation, compared with 3.0% in unexposed infants. After adjusting for maternal age, country and birth year, the difference was not statistically significant. A comparison group of infants exposed to other topical acne treatments, such as azelaic acid or clindamycin, showed similarly unchanged risks.
Topical Retinoids Use in Pregnancy: Researchers Advise Careful Consideration
While the findings are reassuring, the authors caution that focusing only on pregnancies that resulted in live births may underestimate both how often topical retinoids are used during early pregnancy and the true incidence of malformations. Nevertheless, the study provides the strongest evidence to date on the safety of topical retinoids during pregnancy and may help inform clinical guidance.
Experts say the results highlight the importance of continued research, particularly as use of topical retinoids continues to rise among women of reproductive age.
Reference
Refsum E et al. 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;doi:10.1093/bjd/ljaf500
