Vyvanse

THE SAFETY OF LISDEXAMFETAMINE DIMESYLATE (VYVANSE) DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:

Lisdexamfetamine use during pregnancy is associated with an increased risk of preterm delivery and low birth weight. The risk of long-term neurodevelopmental changes and birth defects is uncertain. Breastfeeding is discouraged in women taking lisdexamfetamine.

What is lisdexamfetamine?

Lisdexamfetamine is a stimulant medication related to amphetamine, dextroamphetamine, and methamphetamine.

What is lisdexamfetamine used to treat?

Lisdexamfetamine is a controlled prescription medication used to treat attention deficit hyperactivity disorder (ADHD) in children over 6 years of age and adults. ADHD is a brain disorder characterized by inattention (disorganization and difficulty focusing), impulsive behaviors (acting or speaking without thinking), and/or hyperactive behaviors (restlessness and constant movement). Without proper identification and treatment, many people with ADHD struggle academically, at work, or socially. You can read more about ADHD during pregnancy here. Lisdexamfetamine is also used to treat moderate to severe binge eating disorder in adults.

How does lisdexamfetamine work?

Once absorbed into the body, lisdexamfetamine is converted into dextroamphetamine. Dextroamphetamine stimulates the brain and spinal cord by releasing the neurotransmitters dopamine and norepinephrine, and decreasing their reuptake. Elevated dopamine and norepinephrine increase excitement and mental clarity as well as decreasing appetite.

If I am taking lisdexamfetamine, can it harm my baby?

There is limited information available on the safety of lisdexamfetamine in pregnancy. Lisdexamfetamine is expected to cross the human placenta to reach the developing baby. Studies show that stimulant medications can decrease blood flow to the placenta, causing low birth weight and premature delivery. Lisdexamfetamine can also stimulate uterine contractions, leading to premature delivery. Infants exposed to lisdexamfetamine in utero can develop withdrawal symptoms after birth including irritability, sleepiness, and feeding difficulties.

Animal studies suggest that in utero lisdexamfetamine exposure can cause long-term neurological and developmental changes in infants and may increase the risk of birth defects with high doses of the medication. Lisdexamfetamine should only be used in pregnant women when the maternal benefits justify the potential negative side effects in the baby. One large study of infants exposed to in utero lisdexamfetamine found more of these infants required longer hospitalized and higher level intensive care compared to infants not exposed to lisdexamfetamine. A Swedish study found greater risk for preterm delivery and nervous system disorders including seizures in infants exposed to ADHD medications during pregnancy.

There have been a few case reports of heart defects linked to in utero lisdexamfetamine exposure, but studies remain mixed and have failed to prove a direct link between lisdexamfetamine use during pregnancy and heart defects. A recent study suggests methylphenidate, not amphetamine, used during the first trimester may be associated with a small increase in risk of heart defects, but further study is required. Studies of amphetamine show that abuse of these medications and the associated lifestyle of amphetamine abusers can increase the risk of brain and eye defects in newborns. The National Birth Defects Prevention Study identified a greater risk for the intestine or abdominal organs to develop outside the body and a greater risk for limb defects in infants exposed to ADHD medications in early pregnancy. One study found stimulants such as lisdexamfetamine may be associated with preeclampsia in the mother.

If I am taking lisdexamfetamine and become pregnant, what should I do?

Women who are attempting to conceive or become pregnant while on lisdexamfetamine should speak with their doctor. Caution is advised when continuing lisdexamfetamine therapy during pregnancy. Lisdexamfetamine use during pregnancy has been linked to poor growth in the developing baby, prematurity, and symptoms of withdrawal. There is also a risk of long-term changes in infant neurologic development and behavior. 

If I am taking lisdexamfetamine, can I safely breastfeed my baby?

Lisdexamfetamine is expected to pass into breast milk. It is estimated that infants are exposed to 2% to 13.8% of the mother’s dose. The impact of exposure to this medication on neurodevelopment in nursing infants is unknown. The negative impact on neurological development and behavior may be bigger if a mother is abusing lisdexamfetamine compared to using the medication as prescribed. High levels of lisdexamfetamine for long periods of time may disrupt milk production in women who are nursing infants. There is potential for negative side effects in infants exposed to lisdexamfetamine through nursing including changes in blood pressure and heart rate, poor growth, and negative effects on the infant heart. Due to the possible risk of these side effects and the unknown effects on neurodevelopment and behavior, breastfeeding should be discouraged in women who must continue lisdexamfetamine therapy.

If I am taking lisdexamfetamine, will it be more difficult to get pregnant?

Amphetamine medications like lisdexamfetamine have not been associated with negative effects on fertility in animal studies. Lisdexamfetamine abuse may increase the risk of sexual dysfunction.

If I am taking lisdexamfetamine, what should I know?

Lisdexamfetamine should only be used during pregnancy if the benefits to the mother justify the risks to the developing baby. There may be an increased risk of low birth weight and preterm delivery associated with this medication. The long-term effects on neurological and developmental behavior are unknown. Breastfeeding is discouraged in women taking lisdexamfetamine.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of lisdexamfetamine during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert report about ADHD here,  and reports about the individual medications used to treat mental health conditions here.   Additional information can also be found in the resources below. 

For more information about lisdexamfetamine during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

               Shire:  Vyvanse Prescribing Information

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General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.