Trandate

THE SAFETY OF LABETALOL HYDROCHLORIDE 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:

Studies suggest labetalol hydrochloride use for high blood pressure during pregnancy poses a low risk of harm to the developing baby. However, labetalol hydrochloride exposure near delivery can cause slowed heart rate, respiratory depression, low blood sugar, or low blood pressure in newborns. Breastfeeding infants exposed to labetalol hydrochloride through the mother’s breast milk can develop a slowed heart rate or low blood sugar. Caution is advised when using this medication while nursing an infant.

What is labetalol hydrochloride?

Labetalol hydrochloride is a medication that is taken to treat high blood pressure (hypertension). It is currently available as a generic or brand name medication. Brand names of labetalol hydrochloride include Trandate™ or Normodyne™. Labetalol hydrochloride is available as an oral tablet or an intravenous solution. Oral tablets are used to treat chronic high blood pressure and are taken once or twice daily. Intravenous solution is administered for acute high blood pressure and is dosed based on body weight in children. Intravenous labetalol hydrochloride is either administered in one dose or continuously infused. Labetalol hydrochloride is available by prescription from your doctor.

What is labetalol hydrochloride used to treat?

Labetalol hydrochloride is used to treat acute (short episode) or chronic (continuing) high blood pressure in children, adolescents, and adults. Off-label uses of this medication include chronic high blood pressure during pregnancy and high blood pressure after a stroke. Several types of high blood pressure can affect pregnant women including preeclampsia/eclampsia. Preeclampsia is characterized by high blood pressure during pregnancy and the presence of proteins in the urine.

How does labetalol hydrochloride work?

Labetalol hydrochloride works by decreasing the activity and effects of certain chemicals in the brain (epinephrine and norepinephrine), causing a slowed heart rate and decreased blood pressure. 

If I am using labetalol hydrochloride, can it harm my baby?

Available studies suggest labetalol hydrochloride poses minimal risk to the developing baby except during the first trimester of pregnancy. Untreated high blood pressure or preeclampsia during pregnancy can cause harm to both mother and baby. Severe maternal high blood pressure may be a more appropriate reason to use labetalol hydrochloride during pregnancy compared to mild or moderate high blood pressure. Labetalol hydrochloride use near delivery requires 1-2 days of monitoring the baby for signs of slowed heart rate, respiratory distress, poor growth, or low blood pressure. It is recommended to weigh the benefits to the mother against the risks to the baby before using this medication for maternal high blood pressure. 

Evidence from animal studies with labetalol hydrochloride:

Animal studies have not shown a risk of harm to the offspring with labetalol hydrochloride exposure during pregnancy. When given orally to pregnant rats and rabbits at doses 6 and 4 times the maximum recommended human dose, there was no harm to the babies reported. However, doses similar to the maximum recommended human dose caused embryo loss or decreased weight of the babies in pregnant rats and rabbits. Intravenous doses 1.7 times the maximum recommended human dose in rabbits caused no harm to the babies.  

Evidence for the risks of labetalol hydrochloride in human babies:

Labetalol hydrochloride crosses the human placenta to reach the developing baby. A Michigan Medicaid study in 29 infants exposed to labetalol hydrochloride in utero during the first trimester found a 13.8% risk of major birth defects – much higher than the rate of major birth defects in the general population, which is 4%. The National Birth Defects Prevention Study found no association between urethral birth defects in male infants and labetalol hydrochloride exposure during pregnancy. One study found an increased risk of cleft palate, neural tube defects, and heart defects with first trimester labetalol hydrochloride exposure. In 3300 pregnancies exposed to labetalol hydrochloride during pregnancy, there was no association between heart defects and labetalol hydrochloride. There have been no reports of negative effects on birth weight, head size, eyes, neurologic development, or blood sugar control after in utero exposure to labetalol hydrochloride. A study in 32 young children exposed to labetalol hydrochloride in utero to treat maternal high blood pressure found no evidence of negative long-term effects on neurological development or intelligence. Two studies suggest there may be an increased risk of attention deficit hyperactivity disorder (ADHD) with in utero labetalol hydrochloride exposure. Studies suggest infants exposed to labetalol hydrochloride versus other blood pressure medications in utero can have greater birth weight. However, other studies in women exposed to labetalol hydrochloride for mild preeclampsia suggest infants exposed to labetalol hydrochloride can have restricted growth. 

There have been some reports suggesting labetalol hydrochloride exposure due to maternal high blood pressure can cause slowed heart rate and low blood sugar in newborns, particularly with labetalol hydrochloride use near the time of delivery. Two small studies found mixed evidence to suggest labetalol hydrochloride exposure impacts brain oxygenation in newborn babies. In women with severe high blood pressure, labetalol hydrochloride can decrease the risk of death of the baby and the risk of Cesarean sections and maternal low blood pressure. Studies have shown conflicting results related to the risk of spontaneous labor from exposure to this medication. The use of labetalol hydrochloride to treat maternal high blood pressure is associated with an increased risk of respiratory distress and hospitalization in newborns. Labetalol hydrochloride does not negatively affect placental blood flow and may even protect a premature newborn from developing respiratory distress. Intravenous labetalol hydrochloride is suggested to be effective for late-onset high blood pressure in pregnant women. Oral labetalol hydrochloride is recommended for the treatment of chronic high blood pressure in pregnant women. Intravenous labetalol hydrochloride is recommended for acute, severe high blood pressure during pregnancy and the postpartum period. Labetalol hydrochloride is not recommended in women with asthma, chronic heart failure, or heart disease. 

Bottom line: Studies in pregnant women with high blood pressure suggest labetalol hydrochloride is associated with a low risk of harm to the baby. However, further study is required to identify the risks of labetalol hydrochloride exposure on long-term neurological development. Labetalol hydrochloride administration near the time of delivery may be associated with low heart rate and low blood sugar in newborns and close monitoring is recommended.

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

If you are using labetalol hydrochloride 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 labetalol hydrochloride, can I safely breastfeed my baby?

Labetalol hydrochloride is excreted into the breast milk. Exposure of a nursing infant to this medication is expected to be minimal and pose a low risk of harm to the infant. Nursing infants are estimated to be exposed to 3.6% of a mother’s dose of labetalol hydrochloride. There have been no reports of adverse events in infants exposed to labetalol hydrochloride through breast milk; however, it is recommended to monitor nursing infants exposed to this medication for signs of slowed heart rate and low blood pressure. Long-term developmental effects from exposure to this medication while breastfeeding is unknown. The American Academy of Pediatrics and the World Health Organization identifies labetalol hydrochloride as compatible with breastfeeding. O
ther medications may be recommended to treat maternal high blood pressure for mothers with preterm babies. Intravenous labetalol hydrochloride is associated with an increase in milk production. It is recommended to weigh the risks versus benefits of this medication before using it during pregnancy. Caution is advised when using labetalol hydrochloride while breastfeeding a baby. 

Bottom line: Labetalol hydrochloride is expected to pass into human breast milk. The American Academy of Pediatrics recognized labetalol hydrochloride as compatible with breastfeeding. There have been no reports of adverse events in infants exposed to labetalol hydrochloride through breast milk; however, it is recommended to monitor nursing infants exposed to this medication for signs of slowed heart rate and low blood pressure. Caution is recommended in women using this medication while breastfeeding babies.

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

There are reports of increased time to ejaculation in men and decreased vaginal wetness in women exposed to single doses of labetalol hydrochloride. This could possibly reduce fertility.

If I am using labetalol hydrochloride, what should I know?

Studies in pregnant women with high blood pressure suggest labetalol hydrochloride is associated with a low risk of harm to the baby. However, the use of labetalol hydrochloride near delivery can increase the risk of slowed heart rate, low blood pressure, respiratory depression, and low blood sugar in newborns, so close monitoring is recommended.

The American Academy of Pediatrics recognized labetalol hydrochloride as compatible with breastfeeding. There have been no reports of adverse events in infants exposed to labetalol hydrochloride through breast milk; however, it is recommended to monitor nursing infants exposed to this medication for signs of slowed heart rate and low 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 labetalol hydrochloride during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

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

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

American Heart Association: The Facts About High Blood Pressure

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

ACOG: Preeclampsia and Hypertension in Pregnancy: Resource Overview

U.S. National Library of Medicine:  LABETALOL HYDROCHLORIDE

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.