Is it Safe to Use Atomoxetine (Strattera) During Pregnancy?

Is it Safe to Use Atomoxetine (Strattera) During Pregnancy?

Women with attention-deficit/hyperactivity disorder (ADHD) often discontinue ADHD medications during pregnancy, especially if they have milder symptoms. While this approach makes sense in terms of limiting unnecessary exposures in women with milder illness, we have often been surprised by clinical outcomes in this population, specifically when women who were previously high functioning experience significant psychiatric morbidity during pregnancy after discontinuation of ADHD medications.  Supporting these clinical observations is a new research study from our program which indicates that women who stop ADHD medications during pregnancy are more likely to experience significant impairment in family functioning and higher levels of depressive symptoms.

Atomoxetine (Strattera) is a selective norepinephrine reuptake inhibitor that is used to treat ADHD.  Typically, we have recommended discontinuing this medication during pregnancy because there has been sparse data regarding the reproductive safety of this medication. A new study includes data from a large number of atomoxetine-exposed pregnancies and suggests that atomoxetine may be a reasonable option for the treatment of ADHD during pregnancy.

This study included about 2.4 million pregnancies ending in live birth recorded in the population-based nationwide health registers of Denmark, Iceland, Norway, and Sweden (2003-2017) and approximately 1.8 million publicly insured pregnancies ending in live birth recorded in the US Medicaid Analytic eXtract (MAX, 2001-2013) health care claims database. The analysis compared the prevalence of major congenital malformations among pregnancies exposed and unexposed to atomoxetine. 

A total of 990 pregnancies with first trimester exposure to atomoxetine were identified: 368 from the four Nordic countries and 622 from the US. The pooled crude prevalence ratio (PR) for any major congenital malformation was 1.18 (95% CI, 0.88-1.60), and the adjusted PR was 0.99 (95% CI, 0.74-1.34). For cardiac malformations, the adjusted PR was 1.34 (95% CI, 0.86-2.09). For limb malformations, the adjusted PR was 0.90 (95% CI, 0.38-2.16).

Is Atomoxetine an Option for Women During Pregnancy?

Based on this large cohort study including 990 pregnancies with first trimester exposure to atomoxetine, the researchers observed no increase in major congenital malformations overall and no statistically increased risk estimates for cardiac or limb malformations. This information will undoubtedly be very reassuring to women who are treated with atomoxetine.  

Ruta Nonacs, MD PhD

Bröms G, Hernandez-Diaz S, Huybrechts KF, Bateman BT, Kristiansen EB, Einarsdóttir K, Engeland A, Furu K, Gissler M, Karlsson P, Klungsøyr K, Lahesmaa-Korpinen AM, Mogun H, Nørgaard M, Reutfors J, Sørensen HT, Zoega H, Kieler H.  Atomoxetine in Early Pregnancy and the Prevalence of Major Congenital Malformations: A Multinational Study.  J Clin Psychiatry. 2023 Jan 16;84(1):22m14430. Free article.

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