Methylphenidate, Atomoxetine Safe to Use in Pregnancy: New Study
Pregnant women with ADHD who used methylphenidate or atomoxetine were not at higher risk for miscarriage or congenital anomalies in the fetus, finds a new systematic review and meta-analysis.
January 16, 2025
Methylphenidate and atomoxetine use do not increase a pregnant woman’s risk for miscarriage or congenital anomalies in the fetus, finds a new systematic review and meta-analysis published in JAMA Network Open.1
The review included 10 studies involving 16.5 million pregnant women from 6 countries. It is the first study to compare pregnant women with ADHD who took methylphenidate or atomoxetine with pregnant women with ADHD who did not take these medications, as well as with pregnant women who did not have ADHD or take these medications.
The study, which helps to fill in the gaps of a still-evolving research landscape, has critical implications for millions of women of reproductive age. Medications for ADHD including atomoxetine and methylphenidate are classified by the FDA as “pregnancy category C,” indicating a lack of controlled studies. As a result, no definitive guidelines yet exist for prescribers, though recent research has demonstrated that many ADHD medications are safe for use in pregnancy. In 2020, a qualitative review of eight studies found “no convincing evidence to indicate that prenatal exposure to ADHD medication results in clinically significant adverse effects.”2 In 2023, a large population-based register study concluded that taking ADHD medication, including stimulants, while pregnant does not impact the neurodevelopment or growth of the fetus.3
Historically, some research has suggested that using certain ADHD medications during pregnancy may pose risks to the fetus. One such study from 2018 found a slight association between the use of methylphenidate (though not amphetamine) and some cardiac malformations in infants.4
More recent research focused on maternal health has revealed that continued use of ADHD medication during pregnancy may have protective effects for mothers. A 2022 study published in Frontiers in Reproductive Health found that women with ADHD who were unmedicated during pregnancy were significantly more likely than their non-ADHD counterparts to experience adverse health outcomes including depressive episodes, postpartum depression, gestational hypertension, and cardiac disease. Pregnant women with ADHD who took medication, stimulants or non-stimulants, demonstrated lower risks of these conditions.5
ADHD and Pregnancy: Further Research Needed
According to a recent ADDitude survey, just 2% of readers who have been pregnant reported taking ADHD medication during their pregnancies. For some, this was true because their pregnancy pre-dated their ADHD diagnosis; others said they were concerned about the impact of ADHD medications on fetal health. While some readers found the hormonal changes of pregnancy led to an improvement in ADHD symptoms, many encountered the opposite.
“I went through both pregnancies and breastfeeding without my ADHD medication and it was very difficult, especially when I was working while continuing college classes,” says Chrissy, an ADDitude reader in Pennsylvania. “Brain fog and tiredness loomed over me the entire time, which became frustrating and depressing at times, despite staying on my depression medication.”
“I was diagnosed after the birth of my second child,” recounts Daniela, an ADDitude reader in Italy who now takes medication. “So, I was a mess during my first pregnancy with more forgetfulness, more mood swings, and raging paranoia.”
While the new JAMA Network study contributes an important piece to the puzzle of ADHD medication use during pregnancy, the full picture remains incomplete. The investigators explain the study’s limitations include the nonspecific definition of “congenital anomaly” and potential confounding variables related to ADHD severity. “Further studies are needed to support pregnant women with ADHD in facing a comfortable pregnancy,” the authors write.
Sources
1di Giacomo E, Confalonieri V, Tofani F, Clerici M. Methylphenidate and Atomoxetine in Pregnancy and Possible Adverse Fetal Outcomes: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2024;7(11):e2443648. doi:10.1001/jamanetworkopen.2024.43648
2Li L, Sujan AC, Butwicka A, et al. Associations of prescribed ADHD medication in pregnancy with pregnancy-related and offspring outcomes: a systematic review. CNS Drugs. 2020;34(7):731-747. doi:10.1007/s40263-020-00728-2
3Madsen, K. B., Robakis, T. K., Liu, X., Momen, N., Larsson, H., Dreier, J. W., … Bergink, V. (2023). In utero exposure to ADHD medication and long-term offspring outcomes. Molecular Psychiatry, 1–8. doi: 10.1038/s41380-023-01992-6
4Huybrechts KF, Bröms G, Christensen LB, et al. Association Between Methylphenidate and Amphetamine Use in Pregnancy and Risk of Congenital Malformations: A Cohort Study From the International Pregnancy Safety Study Consortium. JAMA Psychiatry. 2018;75(2):167–175. doi:10.1001/jamapsychiatry.2017.3644
5Walsh, C. J., Rosenberg, S. L., & Hale, E. W. (2022). Obstetric complications in mothers with ADHD. Frontiers in reproductive health, 4, 1040824. https://doi.org/10.3389/frph.2022.1040824
