Intuniv

THE SAFETY OF INTUNIV (GUANFACINE) 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:

Intuniv (guanfacine) should only be used during pregnancy if medically necessary, as determined by your doctor. Guanfacine is expected to cross the placenta, where it could expose your baby to its effects. No sufficient and well-controlled studies have looked at the safety of guanfacine during pregnancy. Some experts advise against the use guanfacine during pregnancy and instead recommend the use of alternative medications for the treatment of high blood pressure or ADHD in expecting moms.

What is Intuniv (guanfacine)?

Intuniv contains the active ingredient guanfacine. It is an extended-release tablet, meaning that the effects of the medication last longer, so you only need to take your medication once daily. Guanfacine is also available as immediate-release tablets used to lower blood pressure, but Intuniv is not used for this purpose. This medication is only available by prescription.

What is Intuniv (guanfacine) used to treat?

Guanfacine extended-release tablets are used to treat ADHD. ADHD is a brain disorder characterized by inattention (difficulty focusing and disorganization), hyperactivity (overly active, restless, fidgeting), and/or impulsive behaviors (acting or speaking without thinking). Without proper identification and treatment, many people with ADHD struggle academically, at work, or socially. You can read more about ADHD and pregnancy here.

Guanfacine immediate-release tables are used to treat high blood pressure. When blood flows through your body, it pushes on the walls of your blood vessels with a certain force. This force is called your blood pressure. High blood pressure occurs when this force is consistently higher than normal. It is often called a “silent killer” because some people have no symptoms and are unaware that they have this disease. Over time, high blood pressure can injure your heart and kidneys, or lead to a stroke or heart attack.

How does Intuniv (guanfacine) work?

Guanfacine acts in your brain to affect memory and behavior and improve the symptoms of ADHD. It lowers blood pressure by reducing your heart rate and relaxing or widening your blood vessels to improve blood flow.

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

Guanfacine should only be used during pregnancy if medically necessary, as determined by your doctor. No studies have reported if guanfacine crosses the human placenta to reach the developing baby, but its properties suggest that it could. No adequate and well-controlled studies have looked at the safety of guanfacine during pregnancy. Due to the lack of data, some experts have advised against the use of guanfacine in expecting moms and instead recommend the use of alternative medications for the treatment of high blood pressure or ADHD during pregnancy. 

Animal studies

Studies in rabbits and rats given guanfacine at doses 20 and 70 times the maximum recommended human dose, respectively, showed no evidence of harm to the offspring. Higher doses of 100 and 200 times the maximum recommended human dose in rabbits and rats, respectively, led to side effects in the mom and reduced the chances of survival in the offspring. Guanfacine has been shown to cross the placenta in rats.

Evidence in humans

A small study looked at 30 expecting moms who developed preeclampsia and were treated with guanfacine for 16 to 68 days. No notable changes in heart rate were reported in the developing babies during treatment, and no other side effects caused by guanfacine were reported in the newborns. Six of the babies were born small for their age at birth. However, some experts have suggested that preeclampsia may have contributed to growth restriction in these babies.

Three case reports have followed expecting moms who took guanfacine during pregnancy; all 3 of the moms delivered healthy babies. 

Bottom line: Guanfacine should only be used during pregnancy if medically necessary, as determined by your doctor. This medication is expected to cross the placenta, where it could expose your baby to its effects. Very little data is available on the use of guanfacine in pregnancy. Some experts do not recommend the use guanfacine during pregnancy and instead advise the use of alternative medications for the treatment of high blood pressure or ADHD in expecting moms.

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

If you are taking guanfacine and become pregnant, you should contact your doctor immediately. Your doctor will determine if treatment with guanfacine is medically necessary and if your medication regimen should be adjusted.

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

Caution should be used if guanfacine is taken by breastfeeding women. Your doctor will determine if treatment with guanfacine is medically necessary and if breastfeeding should be continued. Animal studies have shown that guanfacine passes into breast milk in rats. It is unknown whether guanfacine passes into human breast milk, but its properties suggest that it could. If guanfacine passes into breast milk, it could lead to side effects in the breastfed baby. No reports or studies have been found that have described the use of guanfacine in breastfeeding moms, and its effects on the breastfed baby are unknown. Guanfacine can reduce levels of a type of hormone, called prolactin, which may reduce milk production. If guanfacine is taken while breastfeeding, the baby should be monitored for signs of sleepiness or excessive drowsiness. If you notice any of these symptoms, you should contact your doctor immediately. This may be a sign that guanfacine is causing side effects in your baby. Due to the lack of data and the potential for side effects in the baby, some experts have suggested that other medications may be preferred in nursing moms.

Bottom line: Caution should be used if guanfacine is taken by breastfeeding women. Guanfacine is expected to pass into human breast milk, where it could cause side effects in the breastfed baby. Due to the lack of data on the use of guanfacine while nursing, some experts have suggested that alternative medications may be preferred in breastfeeding women.

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

No studies have been found that have looked at the effects of guanfacine on human fertility. Guanfacine may lower prolactin levels, which could affect fertility in both men and women. Animal studies in rats that have looked at guanfacine at doses up to 22 times the maximum recommended human dose found no evidence of impaired fertility.

If I am taking Intuniv (guanfacine), what should I know?  

Guanfacine should only be used during pregnancy if medically necessary, as determined by your doctor. This medication is expected to cross the placenta, where it could expose your baby to its effects. The data available on the use of guanfacine in pregnancy consists of only a few case reports and 1 small study. Some experts do not recommend the use guanfacine during pregnancy and instead advise the use of alternative medications for the treatment of high blood pressure or ADHD in expecting moms.

Caution should be used if guanfacine is taken by breastfeeding moms. Guanfacine is expected to pass into human breast milk, where it could cause side effects in the breastfed baby. Due to the lack of data on the use of guanfacine while nursing, some experts have suggested that alternative medications may be preferred in breastfeeding moms. Your doctor will determine if treatment with guanfacine is medically necessary and if breastfeeding should be continued.

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

This report provides a summary of available information about the use of Intuniv (guanfacine) during pregnancy and breastfeeding. Content is from the product label unless otherwise indicat
ed.

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:

References:

Lexicomp: Guanfacine: drug information

Centers for Disease Control and Prevention: What is ADHD?

American Heart Association: The Facts About High Blood Pressure.

American Heart Association: Why High Blood Pressure is a “Silent Killer.”

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.