Which ADHD medication is approved for use in a pregnant patient?

ADHD Medication Use in Pregnancy

No ADHD medication is formally FDA-approved for use during pregnancy, but methylphenidate and amphetamines (including dexamphetamine and lisdexamfetamine) are the preferred agents when treatment is medically necessary, as they do not appear to increase the risk of major congenital malformations. 1

Evidence-Based Medication Selection

First-Line Options When Treatment is Required

Methylphenidate is the most studied stimulant in pregnancy and does not appear to be associated with major congenital malformations or other significant adverse obstetrical or developmental outcomes. 1 The absolute risk remains low even for the small associations that have been reported:

• A possible increased risk for cardiac malformations (OR 1.59,95% CI 1.02-2.49) translates to an absolute risk of only 1.7%, and other studies have not consistently found this association 1
• A possible increased risk for gastroschisis (aOR 3.0,95% CI 1.2-7.4) is based on one study with possible confounding by indication, and the absolute risk remains extremely small given the population prevalence of gastroschisis is only 0.05% 1

Amphetamines (including dexamphetamine and lisdexamfetamine) are also preferred options, with generally reassuring safety data showing no increase in major congenital anomalies. 1, 2 Lisdexamfetamine is a prodrug that converts to dexamphetamine, so the safety profile is essentially the same 1

Obstetrical Risks to Counsel About

When continuing stimulant therapy during pregnancy, counsel patients about modest increases in certain obstetrical complications:

• Preterm birth risk increases modestly with ADHD medication use, particularly with longer durations of exposure (aOR 1.3,95% CI 1.1-1.6; aRR 1.3,95% CI 1.1-1.55) 1, 3
• For every 30 days of cumulative exposure in late pregnancy, preterm birth risk increases by approximately 7% (aHR 1.07,95% CI 1.02,1.12) 3
• Possible increased risk for preeclampsia (aRR 1.29,95% CI 1.11-1.49), though this association is not consistently found across studies 1

Second-Line Options

Atomoxetine has very limited data in pregnancy and should be reserved for cases where stimulants are contraindicated or have failed. 1, 2 There is insufficient evidence to recommend its routine use during pregnancy 2

Bupropion, when used as an antidepressant, does not appear to increase the rate of congenital anomalies, but it has been associated with a small increased risk of certain cardiovascular malformations with first-trimester exposure. 4, 2

Clinical Decision Algorithm

Step 1: Assess Severity of Functional Impairment

Continue ADHD medication during pregnancy when symptoms cause significant functional impairment, because abrupt discontinuation may worsen maternal mental health and adversely affect fetal development 4

Balance the potential risks of medication exposure against the documented hazards of untreated ADHD, which include spontaneous abortion, preterm birth, and overall functional impairment 4

Step 2: Choose the Safest Effective Agent

• First choice: Methylphenidate (most studied, reassuring safety profile) 1, 2
• Second choice: Amphetamines (dexamphetamine, lisdexamfetamine) if methylphenidate is ineffective or not tolerated 1, 2
• Avoid atomoxetine unless stimulants are contraindicated (insufficient pregnancy data) 2

Step 3: Optimize Dosing Strategy

Use the lowest effective dose that maintains functional capacity 1

For methylphenidate: Refer to CADDRA Guidelines for specific brand dosing recommendations 1

For dexamphetamine: Usual starting dose is 5 mg PO BID for immediate release, increase by 5 mg weekly increments to a maximum of 50 mg per day; for extended-release (Spansule), start 10 mg PO qam, increase by 5 mg increments 1

For lisdexamfetamine: Usual starting dose is 20-30 mg PO qam, titrate by 10 mg weekly to a maximum of 70 mg daily 1

Step 4: Monitor Closely Throughout Pregnancy

• Monitor for preeclampsia, hypertension, and signs of preterm labor 1, 5
• Track fetal growth and development 5
• Assess maternal mental health and functional capacity 4

Critical Safety Considerations

Ceasing dexamphetamine during pregnancy was associated with increased odds of threatened abortion (OR 2.28,95% CI 1.00-5.15) compared to continuing treatment, suggesting that abrupt discontinuation may carry its own risks 5

Women who ceased ADHD medication prior to pregnancy (unexposed group) showed some benefits compared to continuers, including lower risk of preeclampsia (OR 0.58), hypertension (OR 0.32), postpartum hemorrhage (OR 0.57), and neonatal special care unit admittance (OR 0.16) 5 This suggests that where possible, discontinuation of ADHD medication prior to conception may be advisable if functional impairment allows 5

Breastfeeding Considerations

Monitor infants carefully for irritability, insomnia, and feeding difficulty when breastfeeding while taking amphetamines or dexamphetamine (lactation risk category L3) 1

Methylphenidate appears safe during breastfeeding, with very low concentrations detected in infant blood 2

Breastfeeding with clonidine and amphetamines is contraindicated, but there appear to be no safety concerns for methylphenidate, atomoxetine, or bupropion 2

Common Pitfalls to Avoid

• Do not assume all ADHD medications carry equal risk in pregnancy—methylphenidate and amphetamines have the most reassuring data 1, 2
• Do not automatically discontinue medication without assessing functional impairment—untreated ADHD carries its own maternal and fetal risks 4, 5
• Do not use atomoxetine as first-line in pregnancy—insufficient safety data compared to stimulants 2
• Do not forget to counsel about the modest increase in preterm birth risk, particularly with prolonged exposure in late pregnancy 1, 3