Is Vyvanse (lisdexamfetamine) safe to use during pregnancy?

Vyvanse (Lisdexamfetamine) Use During Pregnancy

Vyvanse can be continued during pregnancy if required for daily functioning, as amphetamines do not appear to be associated with major congenital malformations or significant adverse developmental outcomes, though small increased risks for gastroschisis and preeclampsia exist. 1

Safety Profile for Major Malformations

• Amphetamines, including lisdexamfetamine, are not associated with major congenital malformations or significant adverse developmental outcomes. 1
• A 2023 Danish cohort study of 898 children exposed to ADHD medications (including lisdexamfetamine) in utero found no increased risk of neurodevelopmental disorders, vision/hearing impairments, epilepsy, or growth impairment after adjustment for maternal characteristics (adjusted HR 0.97,95% CI 0.81-1.17). 2
• A 2024 U.S. cohort study of over 4 million pregnancies found that amphetamine/dextroamphetamine exposure was not associated with autism spectrum disorder (HR 0.80,95% CI 0.56-1.14), ADHD (HR 1.07,95% CI 0.89-1.28), or any neurodevelopmental disorder (HR 0.91,95% CI 0.81-1.28) after adjustment. 3
• The Massachusetts General Hospital National Pregnancy Registry found no major malformations in 40 infants exposed to lisdexamfetamine in the first trimester (OR 0.39,95% CI 0.09-1.61 for any stimulant compared to controls). 4

Specific Risks to Monitor

Small but measurable risks exist for certain pregnancy complications:

• Gastroschisis: Possible increased risk (adjusted OR 3.0,95% CI 1.2-7.4), though absolute risk remains extremely small given population prevalence of only 0.05%. 1
• Preeclampsia: Possible increased risk (adjusted RR 1.29,95% CI 1.11-1.49). 1
• Preterm birth: Continued stimulant use in the second half of pregnancy may carry a small increased risk (adjusted RR 1.30,95% CI 1.10-1.55). 1
• Spontaneous abortion: Possible increased risk, though confounding by indication (untreated ADHD itself) cannot be ruled out. 1

Clinical Decision-Making Algorithm

If ADHD symptoms cause significant functional impairment:

• Continue Vyvanse at the current effective dose, as the documented risks are very low and do not outweigh benefits for moderate to severe ADHD. 5
• The American College of Obstetricians and Gynecologists states that treatment should not be stopped if required for daily functioning of the pregnant person. 1, 5

If ADHD symptoms are mild and functional impairment is minimal:

• Consider a trial of gradual discontinuation before or early in pregnancy. 5
• Implement non-pharmacological interventions for ADHD. 1

If unable to discontinue:

• Continue at lowest effective dose or consider intermittent use on days when functioning is most critical. 5

Monitoring During Pregnancy

Maternal monitoring:

• Blood pressure checks at each prenatal visit to screen for preeclampsia. 5
• Ensure appropriate maternal weight gain throughout pregnancy. 5
• Monitor for signs of preterm labor, particularly in the second half of pregnancy. 5

Neonatal monitoring:

• Carefully monitor infants for irritability, insomnia, and feeding difficulties after birth. 1
• Watch for poor neonatal adaptation, which may occur in up to 23.6% of exposed infants. 5
• Monitor for appropriate weight gain and developmental milestones. 5

Important Caveats

• Confounding by indication is a major limitation: Women with ADHD may have baseline increased risks for adverse pregnancy outcomes independent of medication use. 5
• Untreated ADHD itself is associated with increased risks for spontaneous abortion and preterm birth, meaning the disease poses risks separate from medication. 5
• Discontinuing medication can lead to worse mental health outcomes and significant functional impairments that may negatively impact the developing fetus. 5
• The FDA label advises that amphetamines cause vasoconstriction and may decrease placental perfusion, and can stimulate uterine contractions increasing premature delivery risk. 6
• Information regarding amphetamine use applies to therapeutic use and does not apply to non-prescribed use in persons with stimulant use disorder. 1

Breastfeeding Considerations

• The FDA label advises women not to breastfeed while taking lisdexamfetamine. 6
• However, the American College of Obstetricians and Gynecologists recommends that treatment should not be stopped if required for daily functioning, as documented risks are very low. 7
• If breastfeeding, monitor infant for irritability, sleep disturbances, feeding difficulties, and appropriate weight gain. 7