Zyban

THE SAFETY OF APLENZIN 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:

Aplenzin (bupropion hydrobromide) should only be used during pregnancy if the benefits of treatment for the mom outweigh potential risks to the baby. Several studies have linked the use of bupropion early in pregnancy with specific birth defects in the heart. Taking bupropion during pregnancy may also increase the risk of miscarriage. Aplenzin should be used with caution if taken while breastfeeding. There have been a few reports of seizures in breastfed babies exposed to bupropion from breast milk.

What is Aplenzin?

Aplenzin (bupropion hydrobromide) is a type of antidepressant that can help improve the symptoms of depression. The active ingredient in Aplenzin is bupropion. This medication is available in extended-release capsules, so the effects of the medication last longer in your body. Aplenzin only needs to be taken once daily. This medication is available by prescription from your doctor.

What is Aplenzin used to treat?

Aplenzin is used to treat seasonal affective disorder (SAD) and depression, also called major depressive disorder (MDD). Depression is a type of mood disorder that causes feelings of continuous sadness, despair, hopelessness, and/or loss of interest in daily activities for at least a 2-week period of time. These feelings can cause symptoms of fatigue, anxiety, changes in sleep patterns, difficulty concentrating, feelings of worthlessness, or thoughts of suicide. While depression can occur at any time, SAD is characterized by feelings of sadness associated with changing seasons. SAD most commonly starts in the late fall and continues until spring or summer.

Moms can also experience postpartum depression. You can read about postpartum depression here and ways to prevent postpartum depression here. You can also read about the differences between postpartum depression and baby blues here.    

How does Aplenzin work?

Aplenzin works by changing the amounts of certain chemicals in your brain that affect mood. The exact way that Aplenzin improves depression symptoms is unknown. Aplenzin affects different brain chemicals than more typical antidepressants, which may make it more effective in some people and less effective in others. 

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

The FDA recommends that Aplenzin should be used during pregnancy only if the benefits of treatment to the mom outweigh the potential risks to the baby. Some studies have associated the use of bupropion during pregnancy with a higher risk of birth defects in the heart.

Evidence:

The manufacturer of bupropion established a pregnancy registry to record the number of birth defects that occurred with the use of bupropion. The registry included 675 women who took bupropion during the first trimester of pregnancy; 24 birth defects were recorded. Of this total number of birth defects, 9 were birth defects in the heart. Despite these reports, bupropion use during the first trimester of pregnancy was not associated with an overall increased risk of birth defects. It was not possible to determine if there was an association between bupropion exposure and birth defects in the heart due to the small number of cases.

A study looked at over 2,700 babies who had a specific type of birth defect in the heart (ventricular septal defect [VSD]). The study found that babies exposed to bupropion during the first trimester of pregnancy had an increased risk for VSD.

Another study looked at 6,853 babies with a major birth defect in the heart. This study found that bupropion use early in pregnancy was associated with a higher risk of certain types of birth defects in the heart (left ventricular outflow tract obstruction [LVOTO]).

One study compared three groups: bupropion exposure during the first trimester (1,213 babies), bupropion exposure outside the first trimester (1,049 babies), and exposure to other antidepressants (not bupropion) in the first trimester (4,743 babies). Bupropion use during the first trimester was not associated with a higher risk of birth defects compared to the other groups. However, several years later, different authors performed a follow-up analysis of the same data to determine if there was an increased risk of specific birth defects, particularly LVOTOs. After this separate analysis, they found that the use of bupropion during the first trimester of pregnancy was associated with a higher risk of these specific birth defects (LVOTOs) in the heart.

Another small study that looked at 136 women who took bupropion during the first trimester of pregnancy found no increased rate of birth defects, but they found higher rates of miscarriage.

Bottom line: Aplenzin should only be used during pregnancy if the benefits of treatment to the mom justify the potential risks to the baby. Several studies have found that bupropion use during the first trimester was associated with a higher risk of specific birth defects in the heart. Taking bupropion during pregnancy may also increase the risk of miscarriage.

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

If you are taking Aplenzin 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 taking Aplenzin, can I safely breastfeed my baby?

The FDA recommends that caution should be used if Aplenzin is given to moms who are breastfeeding. Bupropion passes into breast milk. Based on the limited data that is available, doses of up to 300 mg of bupropion daily produce low amounts of the drug in breast milk and are not expected to cause side effects in breastfed babies. The American Academy of Pediatrics has classified bupropion as a medication whose effects on the breastfed baby are unknown but may be of concern. Data regarding the safety of bupropion in breastfed babies only consists of a few case reports and a small study. Some of these case reports have described breastfed babies who experienced symptoms of seizures after exposure to bupropion from breast milk.

Evidence:

A 6-month old breastfed baby whose mom took bupropion developed symptoms of seizures 3 days after the mom started the medication. These symptoms were possibly related to bupropion.

Another report described a baby who developed severe vomiting and a seizure after being breastfed. The baby’s mom had been taking another type of antidepressant since the birth of her baby and started bupropion 3 weeks prior to the event. The mom also noticed that her baby had other symptoms before the seizure, including unusual movements, sleep problems, and unresponsive behavior followed by sleep. The seizure was likely caused by bupropion, but the other antidepressant may have contributed to the side effects.

A small study compared 3 groups of breastfeeding moms: moms who took bupropion, moms who took another antidepressant, and moms who took a combination of bupropion and another antidepressant. The study found that breastfed babies exposed to the combination of bupropion and another antidepressant experienced significantly more side effects than either group alone. None of the babies exposed to bupropion experienced seizures.

Bottom line: Caution should be used if Aplenzin is used while breastfeeding. This medication passes into breast milk. There have been a few case reports of breastfed babies experiencing seizures after exposure to bupropion through breast milk.

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

There have been no studies looking at the effects of Aplenzin on fertility in men or women. However, there have been two reported cases of women who experienced menstrual irregularities after taking bupropion.

If I am taking Aplenzin, what should I know?

Aplenzin should only be used during pregnancy if the benefits of treatment to the mom outweigh potential risks to the baby. There have bee
n several studies that have associated the use of bupropion during pregnancy with a higher risk of specific birth defects in the heart. Bupropion may also increase the risk of miscarriage.

Aplenzin should be used with caution in moms who are breastfeeding because it passes into breast milk. There have been a few cases of seizures occurring in breastfed babies exposed to bupropion through breast milk.  

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

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

You may find Pregistry's expert report about depression here, reports about other mental health disorders here, and reports about the individual medications used to treat mental health disorders here.   Additional information can also be found in the resources below. 

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

WebMD: Major Depression (Clinical Depression)

Mayo Clinic Staff: Season Affective Disorder (SAD)

National Institute of Mental Health: Seasonal Affective Disorder

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.