Levosalbutamol

THE SAFETY OF ALBUTEROL 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:

Inhaled albuterol is the preferred treatment option for asthma during pregnancy due to the risk of negative maternal and fetal effects associated with poorly controlled or uncontrolled asthma during pregnancy. There have been limited human studies that have looked at the safety of albuterol during pregnancy, but available evidence is not conclusive on the risk of birth defects with use of this medication during pregnancy, particularly during the first trimester. Albuterol is generally considered compatible with breastfeeding. Cautious administration of albuterol during pregnancy along with maternal/fetal observation are required.

What is albuterol?

Albuterol is a medication that is taken to control the symptoms of asthma in children and adults. Albuterol is currently only available as a brand name medication (for example, Proventil, ProAir, or Ventolin). Albuterol is available in tablet, syrup, metered-dose inhaler, and nebulization solution. The oral forms of albuterol including tablet and syrup are not recommended for treating asthma. It is only available by prescription from your doctor. 

What is albuterol used to treat?

Albuterol is used to treat narrowing of the airways (bronchospasm) associated with acute exacerbations of asthma; albuterol is also used to prevent exercise-induced bronchospasm. During pregnancy, women with asthma may see either a worsening or improvement in their asthma symptoms. Asthma attacks are most common between weeks 17 and 24 during pregnancy. Pregnant women with asthma should undergo regular monitoring and avoid asthma triggers during their pregnancy. 

How does albuterol work?

Albuterol works by binding to beta-2 receptors in the lungs to relax the smooth muscle of the airway, opening up the lungs so that the user can breathe more easily. 

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

There are limited human studies or case reports that have looked at the safety of this medication in pregnancy. Animal studies show that taking albuterol during pregnancy may cause harm to your baby. Uncontrolled or poorly controlled asthma during pregnancy has been associated with harm to both the mother and baby (for example: preeclampsia, preterm birth, low birth weight, and even death). The American College of Obstetrics and Gynecologists recommends inhaled albuterol as the preferred short-acting treatment option for asthma symptoms during pregnancy. 

Evidence from animal studies with albuterol:

When given to pregnant rats at lower doses than the maximum recommended inhaled human dose, albuterol was found to cause cleft palate in 4.5% of developing babies. At 8 times the maximum recommended inhaled human dose, cleft palate occurred in 9.3% of developing babies. No adverse effects were noted in rats given 1/11 the recommended human dose. Pregnant rabbits exposed to an oral dose of albuterol several times the maximum recommended dose had 37% of developing babies with a birth defect of the skull, reduced birth weight, delayed bone development, and a higher rate of stillbirths (death of the offspring after 20 weeks of pregnancy). Pregnant rabbits exposed to 1/3 of the maximum recommended inhaled human dose of albuterol had enlargement of the baby's skull. 

Evidence for the risks of albuterol in human babies:

There have been several case reports of women on oral or intravenous albuterol during pregnancy giving birth to healthy babies. A study in twin babies whose mothers were either exposed to albuterol or placebo during pregnancy found no difference in gestation length, birth weight, or other outcomes; babies exposed to albuterol had less risk for neonatal respiratory distress syndrome. Most human studies have focused on second and third trimester exposure to albuterol, finding no increase in birth defects. A study with first trimester exposure to albuterol in over 1,000 babies reported a possible association between maternal albuterol exposure and polydactyly (extra fingers or toes), but influence of other maternal factors could not be determined. Studies in mothers exposed to albuterol and other asthma medications early during pregnancy have identified a possible increased risk of cleft palate, defects in the arms and legs, defects of the esophagus/stomach/anus, and heart defects in the baby. Because many women in these studies were on multiple medications, no direct link between birth defects and albuterol has been established. High doses of albuterol during labor and delivery require at least 24 hours of monitoring for elevated blood glucose levels in newborns. A 1994 study suggested a possible increase in risk of retinopathy of prematurity (an eye condition causing blindness) with albuterol exposure during pregnancy. A study from 2009 suggested that first and second trimester exposure to albuterol may increase the risk of autism as well as other adverse neurobehavioral effects in babies. 

Albuterol can suppress uterine contractions and has been used off-label for preventing labor; however, there are reports of women suffering adverse events including fluid on the lungs (pulmonary edema) when using albuterol to prevent labor. When used to prevent labor, albuterol can cause temporary elevations in the baby's heart rate. Albuterol can also cause elevations in maternal heart rate and blood glucose. There have been reports of drops in maternal blood pressure, acute congestive heart failure, pulmonary edema, and death with maternal albuterol exposure. Albuterol should be used with caution in women suffering from bronchospasm during labor since the medication can decrease uterine contractions. 

Bottom line: Albuterol is a preferred medication to treat asthma during pregnancy. While human studies are limited, they suggest a possible risk to the baby with first trimester exposure. However, poorly controlled or uncontrolled asthma during pregnancy is expected to pose a greater risk to the baby than albuterol exposure.

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

If you are taking albuterol 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. Albuterol does not have to be stopped because of pregnancy, but overuse should be avoided.

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

The manufacturer recommends evaluating the benefits to the mother and potential harms to the nursing baby before deciding to continue or discontinue breastfeeding. It is unknown if albuterol passes into human breast milk. The amount of albuterol absorbed by the body is expected to be less with inhaled versus oral albuterol dosage forms. Women with asthma are encouraged to breastfeed their newborns, with the World Health Organization considering breastfeeding probably safe if the mother is taking normal doses of albuterol. 

Bottom line: It is not known if albuterol passes into breast milk. Breastfeeding is considered compatible with inhaled albuterol therapy since the amount of medication reaching infant circulation is expected to be minimal.

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

A study in pregnant rats reported that oral albuterol doses 50 times the recommended maximum human dose had no negative effects on fertility.

If I am taking albuterol, what should I know?

Albuterol is recommended for asthma treatment during pregnancy. While human studies are limited, they suggest a possible risk to the baby with first trimester exposure. However, poorly controlled or uncontrolled asthma during pregnancy is expected to pose a greater risk to the baby than in utero albuterol exposure.

Breastfeeding is considered compatible with inhaled albuterol therapy since the amount of medication reaching infant circulation is expected to be minimal.

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

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

You may find Pregistry's expert report abou
t asthma here, and reports about the individual medications used to treat respiratory disorders here.   Additional information can also be found in the resources below. 

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

UpToDate: Patient education: Asthma and pregnancy (Beyond the Basics)

Centers for Disease Control and Prevention: Key Findings: Maternal Asthma Medication Use and the Risk of Selected Birth Defects

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.