Maintenance Use of ADHD Therapies May Be Safe in Pregnancy

Maintenance use of methylphenidate or atomoxetine to treat ADHD during pregnancy may be safe, according to the results of a systematic review and meta-analysis published in JAMA Network Open.¹

Continued methylphenidate or atomoxetine use may be safe, but additional studies are needed. | Image credit: LiezDesign - stock.adobe.com

The estimated prevalence of ADHD among adult women in the US is 3.2%. If untreated, ADHD symptoms may interfere with everyday life, and adult women with ADHD may be more affected by anxiety, depression, substance use disorders, and self-injury.²

Treatment for ADHD is the same in both men and women: the most commonly prescribed medications are methylphenidate, a stimulant, and atomoxetine, a selective norepinephrine reuptake inhibitor. There are no “definitive guidelines or clear indications” on the safety of these drugs during pregnancy, and the FDA classifies ADHD drugs as “pregnancy category C”—indicative of a lack of controlled studies.

Through a systematic review and meta-analysis, researchers sought to evaluate possible adverse effects—specifically, congenital anomalies or miscarriages—in pregnant women who did and did not receive ADHD treatment during pregnancy.

A total of 10 good or high-quality studies, including 16,621,481 women, 30,830 of whom had ADHD, across 6 countries were identified. Investigators found that congenital anomalies were slightly more frequent in babies born to women who received ADHD therapy during pregnancy, compared with those who did not, although the result was not statistically significant (OR, 1.14; 95% CI, 0.83-1.55). Rates of miscarriage were similar, and were not statistically significant (OR, 1.01; 95% CI, 0.70-1.47).

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Compared with the general population, both congenital anomalies and miscarriage were more frequent, but again, did not reach statistical significance (OR, 1.19; 95% CI, 0.93-1.53 for congenital anomalies and OR, 1.05; 95% CI, 0.81-1.37 for miscarriage).

“To our knowledge, this is the first extensive meta-analysis involving more than 16 million pregnant women that examines possible adverse outcomes in the offspring of mothers with ADHD who take specific drug therapies…during pregnancy compared with mothers with the same pathology but without prescription during pregnancy and the general population,” the researchers wrote.

Study limitations include the nonspecific definition of congenital anomaly; investigators noted that “the term does not imply the level of seriousness or any specificity of the anomaly.”

“Methylphenidate and atomoxetine intake during pregnancy were not associated with higher frequencies of congenital anomalies or miscarriages in this meta-analysis,” the investigators concluded. “Further studies are needed to support pregnant women with ADHD in facing a comfortable pregnancy.”

READ MORE: Women’s Health Resource Center

References

1. Di 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

2. Owens EB, Zalecki C, Gillette P, Hinshaw SP. Girls with childhood ADHD as adults: Cross-domain outcomes by diagnostic persistence. J Consult Clin Psychol. 2017;85(7):723-736. Doi:10.1037/ccp0000217