Paternal Acitretin Exposure Does Not Increase Risk for Miscarriage, Congenital Malformations

A study addresses concerns about paternal acitretin exposure before and during pregnancy and finds no increased risk for miscarriage or major malformations.

The risk for miscarriage or major congenital malformations do not appear to be a concern among pregnancies exposed to paternal acitretin 12 months before conception and to the end of the first trimester, according to study data published in the Journal of the American Academy of Dermatology.

The study included all registered pregnancies in Denmark from 1997 to 2016 (n=1,477,252). Pregnancy data were obtained from the Medical Birth Registry and National Hospital Registry. In addition, the National Prescription Registry was used to identify paternal exposure to acitretin, a highly teratogenic oral retinoid used to treat psoriasis and acne.

Researchers compared the risks for miscarriage and major congenital malformations in pregnancies exposed to paternal acitretin approximately 12 months prior to conception to the end of the first trimester with pregnancies without paternal acitretin exposure. The extended half-lives of acitretin metabolites guided the selection of the preconception 12-month timeline.

A total of 244 pregnancies in this Danish cohort were exposed to paternal acitretin in the 12 months prior to conception and during the first trimester. A lower percentage of exposed pregnancies experienced a miscarriage vs the unexposed pregnancies (6% vs 9%, respectively; adjusted hazard ratio [aHR], 0.71; 95% CI, 0.43-1.17). Of the 117 acitretin-exposed pregnancies in the 3 months prior to conception, 7% of pregnancies experienced a miscarriage compared with 9% among unexposed pregnancies (aHR, 0.76; 95% CI, 0.38-1.51).

Approximately 4% (n=8) of children with fathers exposed to acitretin within the 12 months prior to conception and to the end of the first trimester were diagnosed with a congenital malformation. There were 5 children with a diagnosed malformation who were exposed to acitretin 3 months prior to conception (aOR, 1.60; 95% CI, 0.65-3.95) and 5 children who were exposed during first trimester (aOR, 1.93; 95% CI, 0.78-4.79). The same percentage (4%) of children with unexposed fathers were also diagnosed with a malformation (n=40,560; adjusted odds ratio [aOR], 1.15; 95% CI, 0.57-2.34).

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The primary limitations of this analysis were the lack of data on acitretin compliance and prescribed doses of acitretin.

According to the investigators, paternal exposure to acitretin “before and during pregnancy do not appear to be of major concern, but further studies are recommended.”

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Noergaard M, Clausen SS, Andersen JT. Paternal acitretin exposure and the risk of miscarriage and major congenital malformations: a nationwide register-based cohort study [published online March 16, 2020]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2020.01.073