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

Women with attention-deficit/hyperactivity disorder (ADHD) often discontinue ADHD medications while pregnant, especially in the event that they have milder symptoms. While this approach is smart when it comes to limiting unnecessary exposures in women with milder illness, we have now often been surprised by clinical outcomes on this population, specifically when women who were previously high functioning experience significant psychiatric morbidity while pregnant after discontinuation of ADHD medications.  Supporting these clinical observations is a latest research study from our program which indicates that girls who stop ADHD medications while pregnant usually tend to experience significant impairment in family functioning and better levels of depressive symptoms.



Atomoxetine (Strattera) is a selective norepinephrine reuptake inhibitor that’s used to treat ADHD.  Typically, we have now really useful discontinuing this medication while pregnant because there was sparse data regarding the reproductive safety of this medication. A brand new study includes data from a lot of atomoxetine-exposed pregnancies and suggests that atomoxetine could also be an inexpensive option for the treatment of ADHD while pregnant.

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

A complete of 990 pregnancies with first trimester exposure to atomoxetine were identified: 368 from the 4 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 huge 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’re 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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