From the Guidelines
Elvanse (lisdexamfetamine) should be used with caution during pregnancy and only when the benefits clearly outweigh the risks, as the current evidence suggests potential risks of premature birth, low birth weight, or withdrawal symptoms in newborns 1.
Key Considerations
- The decision to continue or discontinue Elvanse during pregnancy should be made collaboratively with a healthcare provider, weighing the mother's mental health needs against potential fetal risks.
- There is limited research on Elvanse's effects during pregnancy, but stimulant medications may potentially increase risks of pregnancy and birth complications.
- For women with ADHD who become pregnant, healthcare providers typically reassess the necessity of medication, considering non-pharmacological approaches first.
- If medication is deemed necessary, the doctor might suggest lower doses, intermittent use, or alternative treatments with better-established safety profiles during pregnancy.
Management Recommendations
- Regular prenatal care is essential if Elvanse is continued during pregnancy to monitor both the mother's health and the baby's development.
- Providers should work collaboratively with patients and their support networks to balance the risks of perinatal ADHD medication with the risks of inadequately treated ADHD during pregnancy 1.
- Preconception counseling and appropriate perinatal planning, management, and support can help manage the risks and impacts of ADHD in pregnancy 1.
From the FDA Drug Label
The limited available data from published literature and postmarketing reports on use of lisdexamfetamine dimesylate capsules in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers dependent on amphetamines In animal reproduction studies, lisdexamfetamine dimesylate (a prodrug of d-amphetamine) had no effects on embryo-fetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis.
Use in Pregnancy: The FDA drug label does not provide sufficient information to determine the safety of Elvanse (lisdexamfetamine) in pregnancy.
- Key Points:
- Limited data available on use in pregnant women
- Adverse pregnancy outcomes seen in infants born to mothers dependent on amphetamines
- Animal studies show no effects on embryo-fetal development, but amphetamine exposure can cause long-term neurochemical and behavioral alterations 2 The FDA drug label does not answer the question.
From the Research
Elvanse in Pregnancy
There are no direct studies on the use of Elvanse (lisdexamfetamine) in pregnancy among the provided evidence.
- The studies provided focus on the efficacy and safety of lisdexamfetamine in adults and children with attention-deficit/hyperactivity disorder (ADHD) 3, 4, 5, 6.
- One study discusses the use of non-steroidal anti-inflammatory drugs (NSAIDs) in pregnancy, which is not relevant to Elvanse 7.
- None of the studies provide information on the safety or efficacy of Elvanse during pregnancy.
- Therefore, there is no evidence to assist in answering this question about the use of Elvanse in pregnancy.