Catapres

THE SAFETY OF CLONIDINE 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 information available on the safety of clonidine during pregnancy; however, available studies suggest the use of clonidine during pregnancy poses a low risk of harm to the baby. There have been reports of transient high blood pressure in newborns exposed to clonidine late in pregnancy, but there is no evidence that clonidine increases the risk of birth defects. There have been reports of side effects associated with exposure to clonidine in breastfeeding infants as well as adverse effects on maternal milk production. It is recommended that you use this medication only after weighing the potential risks versus benefits of use during pregnancy or while breastfeeding.

What is clonidine?

Clonidine is a prescription medication currently available as a generic or a brand name. Brand names of clonidine include Catapres™, Kapvay™, and Duraclon™. Catapres™ is available as an oral tablet or transdermal patch. Duraclon™ is available as a solution for epidural administration. Kapvay™ is available as an extended release oral tablet. Clonidine patches are reapplied every 7 days. Other forms of clonidine are dosed based on patient age and indication. When used to treat high blood pressure, clonidine can not be stopped abruptly, but must be gradually discontinued to avoid rebound high blood pressure. 

What is clonidine used to treat?

Clonidine is used as an alternative agent to treat high blood pressure in adults. It has also been used off-label for sedation in the intensive care unit and for opioid withdrawal in adults. In children over 6 years of age and adolescents, clonidine is used to treat high blood pressure, for epidural analgesia, neuropathic pain, sedation in the intensive care unit, Tourette’s syndrome, and for attention deficit hyperactivity disorder (ADHD). 

High blood pressure is one of the most common complications in pregnant women. Untreated maternal high blood pressure has been associated with an increased risk of low birth weight, birth defects, prematurity, stillbirth, and death of the baby, as well as preeclampsia and other maternal complications after delivery. 

You can read more about high blood pressure in pregnancy here. You can read more about ADHD and pregnancy here.

How does clonidine work?

Clonidine works by changing nerve impulses originating from the brain and spinal cord, which decrease resistance to blood flow in blood vessels and decreases blood pressure.

If I am using clonidine, can it harm my baby?

There is limited information available on the use of clonidine during pregnancy. However, the available evidence suggests clonidine more than likely poses a low risk to the developing baby when used during pregnancy. Clonidine is not a first-line agent to treat high blood pressure and is recommended during pregnancy only if clearly needed. It is recommended that you use this medication only after weighing the potential risks versus benefits of use during pregnancy. 

Evidence from animal studies with clonidine:

When given to pregnant mice and rats at doses up to several times the maximum recommended human dose, there was decreased fetal survival reported. No birth defects have been reported in pregnant mice, rabbits, and rats given clonidine at doses above the maximum recommended human dose. Doses of oral clonidine up to three times the maximum recommended human dose did not cause adverse effects in offspring. Lethal doses of clonidine have been associated with decreased growth and cleft palate in mice. Changes in behavior and weight of animal offspring exposed to clonidine in utero have been reported. 

Evidence for the risks of clonidine in human babies:

Clonidine is expected to cross the human placenta to reach the developing baby. A study in Michigan Medicaid recipients reported three out of 59 newborns exposed to clonidine during the first trimester developed birth defects. There was no pattern of birth defects; however, two of the three newborns with birth defects had heart defects. Two hundred who received clonidine during the second or third trimester of pregnancy found no increase in birth defects. No reports of low blood pressure in exposed newborns have been reported. However, there have been reports of temporary high blood pressure during the first three days after delivery in newborns exposed to clonidine in later pregnancy. Newborns exposed to clonidine during pregnancy had similar neurologic exams, blood sugar, and electrolyte levels as newborns not exposed to clonidine during pregnancy. Case reports of clonidine use during conception and early pregnancy suggest there is minimal risk with exposure to this medication. There have been reports of hyperactivity and sleep changes in six year old children exposed to clonidine during pregnancy. A 2010 study found that women who experienced a decrease in heart rate with clonidine use during pregnancy were more likely to have low birth weight newborns. 

Bottom line: Studies in pregnant women who were exposed to clonidine during pregnancy suggest there is no increase in the risk of birth defects. There have been reports of transient high blood pressure in newborns exposed to clonidine in late pregnancy. Animal studies suggest there may be potential risks with exposure to clonidine during pregnancy. It is recommended that you use this medication only after weighing the potential risks versus benefits of use during pregnancy.

If I am using clonidine and become pregnant, what should I do?

If you are using clonidine and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medication is medically necessary, or if it should be discontinued until after the birth of your baby.

If I am using clonidine, can I safely breastfeed my baby?

Clonidine is excreted into breast milk. Concentrations of clonidine in breast milk have been estimated to be four times greater than in the mother's blood. There are reports detailing adverse effects of clonidine exposure on breastfeeding infants including apathy syndrome, low blood sugar, low muscle tone, drowsiness, feeding difficulties, and hyperexcitability. Low blood pressure in nursing infants exposed to clonidine has not been reported. Clonidine may affect milk production due to its effects on prolactin secretion.  It is recommended that you weigh the risks versus benefits of this medication before using it while breastfeeding. Clonidine may not be recommended if you are breastfeeding especially in preterm infants or when high maternal doses of the medication are required. Due to the potential for negative effects on the baby as well as negative effects on milk production and high levels in breast milk, other medications may be recommended to treat maternal high blood pressure. 

Bottom line: Clonidine passes into human breast milk. There have been reports of adverse events in infants exposed to clonidine through breast milk including apathy syndrome, low blood sugar, low muscle tone, drowsiness, feeding difficulties, and hyperexcitability. Clonidine may adversely affect milk production. It is recommended that you weigh the risks versus benefits of this medication before using it while breastfeeding.

If I am using clonidine, will it be more difficult to get pregnant?

Men who were exposed to clonidine developed impotence in some studies. Reports suggest clonidine may decrease arousal in women and negatively affect sperm development in men. 

If I am using clonidine, what should I know?

It is recommended that you use this medication only after weighing the potential risks versus benefits of use during pregnancy. Studies in pregnant women who were exposed to clonidine during pregnancy suggest there is no increase in the risk of birth defects. There have been reports of transient high blood pressure in newborns exposed to clonidine in late pregnancy.

Clonidine passes into human breast milk. There have been reports of adverse events in infants exposed to clonidine through breast milk including apathy syndrome, low blood sugar, low muscle tone, drowsiness, feeding difficu
lties, and hyperexcitability. Clonidine may adversely affect milk production. Due to the potential for negative effects on the baby as well as negative effects on milk production and high levels in breast milk, other medications may be recommended to treat maternal high blood pressure.

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

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

You may find Pregistry's expert reports about hypertension here, high blood pressure here,  ADHD here, and reports about the individual medications used to treat heart and blood conditions here. Additional information can also be found in the resources below. 

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

U.S. National Library of Medicine: LACTMED: CLONIDINE

American Heart Association: The Facts About High Blood Pressure.

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

Centers for Disease Control and Prevention: What is ADHD?

Read the whole report
Last Updated: 10-02-2020
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.