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THE SAFETY OF GUANFACINE HYDROCHLORIDE EXTENDED RELEASE (INTUNIV) 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:

Limited information is available on the safety of guanfacine during pregnancy and breastfeeding. Caution is advised when administering this medication to pregnant or nursing women.

What is guanfacine?

Guanfacine is a non-stimulant medication.

What is guanfacine used to treat?

Guanfacine is a prescription medication used to treat symptoms of attention deficit hyperactivity disorder (ADHD) in children over 6 years old, adolescents, and adults. An immediate release form of guanfacine is used to treat high blood pressure in adults and children over 12 years of age. This particular form of guanfacine is extended release and is used for ADHD. You can read more about ADHD during pregnancy here.

How does guanfacine work?

Guanfacine interacts with the nervous system to decrease pressure in blood vessels, decrease heart rate, and improve behavior and memory through neuronal signaling in the brain.

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

Little safety information is available on guanfacine. In animal studies, guanfacine crosses the placenta to reach the baby. There have been no reports of harm to the babies in animal studies involving guanfacine. There have been three case reports of healthy infants born to women exposed to guanfacine during pregnancy. It is important to remember that uncontrolled ADHD can cause problems for pregnant women and their babies, such as car accidents. Uncontrolled high blood pressure during pregnancy is also unsafe for in women and infants. Guanfacine is not a preferred medication to treat high blood pressure during pregnancy.

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

The risks should be weighed against the benefits of continuing guanfacine during pregnancy. Women who are attempting to conceive or become pregnant while on guanfacine should speak with their doctor. Other medications may be preferred over guanfacine during pregnancy.

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

Guanfacine is expected to pass into breast milk. Guanfacine may decrease milk production in women. Nursing infants exposed to guanfacine can experience sleepiness and sedation. Exercise caution if taking guanfacine while breastfeeding, and monitor your baby for signs of excessive sleepiness. There may be a safer medicine you can take, so talk to your doctor.

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

Based on results from animal studies, guanfacine does not adversely affect fertility.

If I am taking guanfacine, what should I know?

It is important to speak with your doctor to determine if you should be on guanfacine therapy during pregnancy. Guanfacine should only be used during pregnancy if it is needed. Guanfacine exposure in nursing infants has been associated with reports of excessive sleepiness.

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

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

U.S. Food and Drug Administration:  Intuniv 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.