Can a pregnant adolescent with Attention Deficit Hyperactivity Disorder (ADHD) take Strattera (atomoxetine) and Tenex (guanfacine)?

ADHD Medication Use in Pregnant Adolescents

Both Strattera (atomoxetine) and Tenex (guanfacine) can be continued during pregnancy in a pregnant adolescent with ADHD after a thorough risk-benefit discussion, as recent large-scale studies show no increased risk of major congenital malformations with atomoxetine, though guanfacine has extremely limited pregnancy data and alternative agents would be preferred. 1

Atomoxetine (Strattera) in Pregnancy

Safety Profile

• A 2024 meta-analysis of 16.6 million pregnancies found no increased risk of congenital anomalies (OR 1.14,95% CI 0.83-1.55) or miscarriages (OR 1.01,95% CI 0.70-1.47) with atomoxetine exposure during pregnancy compared to unexposed women with ADHD. 2

• A recent large, well-controlled study demonstrated no increased risks for atomoxetine use during pregnancy on developmental outcomes. 1

• The FDA label states that available published studies with atomoxetine in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 3

Potential Concerns

• A 2025 population-based cohort study of 11,075 pregnancies found that ≥2 filled prescriptions of ADHD medications in early pregnancy was associated with modestly higher preterm birth risk (aRR 1.29,95% CI 1.08,1.53), with atomoxetine showing particular association in early pregnancy. 4

• Animal studies showed decreased pup weight and survival at doses 5-6 times the maximum recommended human dose, though no adverse fetal effects were seen in rats dosed during organogenesis alone. 3

Clinical Recommendations

• Healthcare providers should register pregnant patients in the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 to contribute to safety data collection. 3

• The 2018 review in Pharmaceutical Research concludes that atomoxetine does not appear teratogenic, but due to paucity of long-term neurodevelopmental data, physicians should reconsider the need for treatment during pregnancy, with methylphenidate and amphetamines being preferred if medication is necessary. 5

Guanfacine (Tenex) in Pregnancy

Extremely Limited Data

• There are no published studies of guanfacine in pregnancy specifically for ADHD treatment. 1

• The only published study evaluated guanfacine for hypertension treatment in 30 patients with preeclampsia, all outside the first trimester, reporting no congenital malformations but 20% of infants had low birth weight (though all developed normally). 1, 6

• The American College of Obstetricians and Gynecologists recommends guanfacine be used with caution in pregnancy due to limited safety data, with the single small study showing concerning rates of low birth weight. 6

Guideline Position

• Guanfacine could be considered in ADHD treatment following a risk-benefit discussion acknowledging the very limited information on its safety in pregnancy, but alternative agents would be preferred. 1

• Guanfacine is not rated by LactMed for pregnancy safety, reflecting the absence of adequate data. 1

Clinical Decision Algorithm

Step 1: Assess Severity and Functional Impairment

• Determine whether ADHD symptoms are causing significant functional impairment that justifies medication continuation during pregnancy. 1

• Consider whether behavioral interventions alone could provide adequate symptom management during pregnancy. 1

Step 2: Medication Selection Priority

If medication is necessary:

1. First choice: Methylphenidate or amphetamines (preferred based on more extensive safety data) 5, 2
2. Second choice: Atomoxetine (acceptable based on recent large-scale safety data showing no increased malformation risk) 2
3. Last choice: Guanfacine (minimal data, alternative agents preferred) 1

Step 3: If Continuing Current Regimen

• For atomoxetine: Can be continued with informed consent discussion about modest preterm birth risk with ≥2 prescriptions in early pregnancy and registry enrollment. 2, 4

• For guanfacine: Should strongly consider switching to atomoxetine or methylphenidate given the absence of pregnancy-specific ADHD data and 20% low birth weight rate in the single hypertension study. 1, 6

Step 4: Monitoring Requirements

• Monitor fetal growth closely given the low birth weight signal with guanfacine and modest preterm birth risk with atomoxetine. 1, 4

• Enroll in the National Pregnancy Registry for ADHD Medications to contribute to safety knowledge. 3

Critical Caveats

Combination Therapy Concerns

• The question asks about both medications together, but there is no safety data on the combination of atomoxetine and guanfacine during pregnancy. 1

• If both medications are currently being used, strongly consider simplifying to monotherapy with the safest option (atomoxetine or preferably methylphenidate). 5, 2

Adolescent-Specific Considerations

• Adolescent pregnancies carry inherently higher risks, making medication decisions even more complex. 1

• Ensure comprehensive prenatal care coordination given the dual challenges of adolescent pregnancy and ADHD management. 1

Long-Term Neurodevelopmental Outcomes

• There are practically no data on possible long-term neurodevelopmental effects of any ADHD medications, which represents a significant knowledge gap. 5

• This uncertainty should be explicitly discussed during informed consent conversations. 5

Breastfeeding Planning

• If planning to breastfeed, note that guanfacine has no published breastfeeding studies, while atomoxetine appears in breast milk but at very low concentrations in infant blood. 1, 5