Tomoxetine

THE SAFETY OF ATOMOXETINE HYDROCHLORIDE (STRATTERA) 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 MAY CAUSE HARM TO YOUR BABY:

There is limited evidence available on the safety of atomoxetine during pregnancy. Atomoxetine should only be used during pregnancy if the potential benefits for the mother outweigh the risks to the developing baby.

What is atomoxetine?

Atomoxetine is a norepinephrine reuptake inhibitor.

What is atomoxetine used to treat?

Atomoxetine is a non-stimulant prescription medication used to treat attention deficit hyperactivity disorder (ADHD). 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.

How does atomoxetine work?

Atomoxetine increases the presence of the neurotransmitter norepinephrine in the brain, which increases stimulation of the brain and spinal cord.

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

There is limited information available on the safety of atomoxetine in pregnancy. Animal studies suggest atomoxetine may be associated with negative side effects in the baby. It is recommended to avoid atomoxetine during pregnancy. For some expecting moms, discontinuing ADHD medications can increase the risk of motor vehicle accidents and impairments at school or work. In these cases, your doctor may decide that atomoxetine is medically necessary.

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

Women of childbearing potential should use effective contraception while taking atomoxetine. Women who are attempting to conceive or become pregnant while on atomoxetine should speak with their doctor. It is important to weigh the risks and benefits of continuing atomoxetine therapy during pregnancy. Caution is advised when continuing atomoxetine therapy during pregnancy. If this medication is continued during pregnancy, it should be given at the lowest dose and not during the first trimester if possible. 

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

It is unknown if atomoxetine passes into the breast milk. Caution is advised if women are taking atomoxetine while nursing infants. Infants who are exposed to atomoxetine through breast milk should be monitored for adverse events such as stomach pain, constipation, and indigestion.

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

Atomoxetine has not been associated with negative effects on fertility in animal studies.

If I am taking atomoxetine, what should I know?

Little information is known concerning the safety of atomoxetine use during pregnancy. Atomoxetine should only be used during pregnancy if the benefits to the mother justify the risks to the developing. Mothers who continue breastfeeding while on atomoxetine should monitor their baby for adverse effects.

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

This report provides a summary of available information about the use of atomoxetine 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 atomoxetine during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

                     Lilly:  Strattera Prescribing Information

Read the whole report
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.