Prozac

THE SAFETY OF PROZAC (FLUOXETINE) 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:

Prozac (fluoxetine) should only be used during pregnancy if the benefits of treatment to the mom outweigh the potential risks to the baby. Some studies have associated the use of fluoxetine during pregnancy with a higher risk of major birth defects, birth defects in the heart, and birth defects in the skull. Taking fluoxetine later in pregnancy can also cause your baby to be born with health problems, such as breathing problems, low blood sugar levels, or seizures.

What is Prozac (fluoxetine)?

Prozac (fluoxetine) is a medication that is taken to relieve the symptoms of depression and some other disorders, such as obsessive-compulsive disorder. Prozac contains the active ingredient fluoxetine. Fluoxetine is available as oral capsules, tablets, liquid, and delayed release tablets that are taken weekly. This medication is only available with a prescription.

What is Prozac (fluoxetine) used to treat?

Fluoxetine is used to treat major depressive disorder. 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 lead to symptoms of anxiety, irritability, fatigue, difficulty concentrating, changes in sleep patterns, feelings of worthlessness, or thoughts of suicide. If left untreated, these symptoms can interfere with your ability to function socially, at work or school, and in daily activities. Moms can also experience postpartum depression after the baby is born. You can read about postpartum depression here and ways to prevent postpartum depression here.

Fluoxetine can also be used to treat obsessive-compulsive disorder, which is a type of anxiety disorder characterized by obsessive and recurring thoughts or repetitive behaviors. You can read more about obsessive-compulsive disorder here. Additionally, fluoxetine may be used to treat bulimia nervosa (an eating disorder) and panic disorders.

How does Prozac (fluoxetine) work?

Fluoxetine is a type of antidepressant called a selective serotonin reuptake inhibitor (SSRI). It works by increasing the amount of a certain chemical (serotonin) in your brain to improve depression symptoms. It is thought that depression, obsessive-compulsive disorder, and some other mental health disorders are caused by lower amounts of some chemicals, including serotonin, in the brain. 

If I am taking Prozac (fluoxetine), can it harm my baby?

Fluoxetine should only be used during pregnancy if the benefits to the mom outweigh the potential risks to the baby, as determined by your doctor. This medication crosses the placenta and can cause harm to your baby. Some studies have associated the use of fluoxetine during pregnancy with a higher risk of birth defects. Taking fluoxetine during the third trimester of pregnancy can cause your baby to have health problems after delivery, including breathing problems, low blood sugar levels, irritability, or seizures. SSRIs have been associated with several other risks to the developing baby, including miscarriage, premature birth, low birth weight, and possible abnormalities in neurological development beyond infancy.

Evidence for birth defects:

Some studies have associated the use of fluoxetine during pregnancy with a higher risk of birth defects. A study that analyzed data from 6 other studies looked at about 3,000 babies who were exposed to fluoxetine during pregnancy. The study found that taking fluoxetine during pregnancy increased the risk of major birth defects and birth defects in the heart. Another study found a higher rate of birth defects in the heart and skull in babies who were exposed to fluoxetine during pregnancy. 

An additional study looked at approximately 6,200 expecting moms who took fluoxetine during the first trimester of pregnancy. Fluoxetine use was associated with a higher risk of major birth defects and birth defects in the heart.

A review compared data from several studies and found that the use of any antidepressant during pregnancy was associated with a higher risk of birth defects in the heart. This review also found that taking fluoxetine during pregnancy was associated with a higher risk of major birth defects. However, when only higher quality studies were compared, this increased risk associated with fluoxetine use was not significant.

Evidence for other risks:

The FDA warns that taking an SSRI, including fluoxetine, late in pregnancy can cause persistent pulmonary hypertension of the newborn (PPHN) and other health problems in your baby. These problems may require hospitalization, respiratory support (to help maintain normal breathing), and nutrition by injection of fluids (due to inability to feed). The health problems that have been reported in babies exposed to SSRIs and other types of antidepressants that work similarly to SSRIs (serotonin and norepinephrine reuptake inhibitors [SNRIs]) are caused by the effects these medications have on serotonin. 

Babies whose moms have taken SSRIs or SNRIs late in the third trimester have developed health problems upon delivery. The following is a list of some health problems that have been reported in babies exposed to either SNRIs or SSRIs.

  • Difficulty breathing
  • Vomiting
  • Difficulty feeding
  • Constant crying
  • Irritability
  • Changes in body temperature
  • Slowed and ineffective breathing
  • Shakiness/jitteriness
  • Low blood sugar levels
  • Seizures
  • Hyperactive reflexes
  • A condition where breathing temporarily stops
  • Poor blood flow or insufficient amounts of oxygen in the blood, leading to bluish colored skin
  • “Floppy baby syndrome” (a condition characterized by too little muscle tone; babies often cannot control their neck muscles)
  • A condition where muscles have too much muscle tone, causing spasms and stiff, rigid limbs

Using SSRIs in late pregnancy may be associated with PPHN, a serious breathing problem in newborn babies that leads to death in around 15% of newborns. A review analyzed 7 studies and found that taking an SSRI late in pregnancy increased the risk of PPHN. Another study looked at approximately 17,053 expecting moms who had used an SSRI during early pregnancy and 11,014 who had used an SSRI after the 20th week of pregnancy. Women who took an SSRI after the 20th week of pregnancy had a 2 times higher risk of delivering a baby with PPHN. The study also found a slightly increased risk of PPHN in expecting moms who had used an SSRI early in pregnancy.

SSRIs may also cause abnormalities in neurological development beyond infancy. A small study found that 2-month-old babies whose moms had taken an SSRI during pregnancy had significantly reduced pain responses. 

Taking SSRIs during pregnancy has been associated with premature birth and low birth weight in some studies. It is unclear if exposure to SSRIs during pregnancy also increases the risk of miscarriage. A study looked at outcomes for 1,279,840 expecting mothers. This study found a higher risk of miscarriage in expecting moms who took an SSRI during the first 5 weeks of pregnancy. However, this increased risk was also found in expecting moms who discontinued SSRI treatment 3 to 12 months before pregnancy. The study suggested that the increased rate of miscarriage may have been due to the underlying disease, smoking, alcohol use, or other factors.

Bottom line: Fluoxetine should only be used during pregnancy if the benefits to the mom outweigh the potential risks to the baby, as determined by your doctor. This medication crosses the placenta and could harm your baby. Some studies have found a higher risk of major birth defects, birth defects in the heart, and
birth defects in the skull with the use of fluoxetine during pregnancy. Additionally, taking fluoxetine later in pregnancy may cause health problems in your baby, including breathing difficulties, low blood sugar levels, shakiness, or seizures.

If I am taking Prozac (fluoxetine) and become pregnant, what should I do?

If you are taking fluoxetine 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 Prozac (fluoxetine), can I safely breastfeed my baby?

Fluoxetine is not recommended for use in breastfeeding moms. This medication passes into breast milk in higher amounts than other SSRIs and can cause side effects in the breastfed baby. Reports have described fussiness, sleepiness, watery stools, vomiting, colic, and sleep disturbances in breastfed babies who were exposed to fluoxetine through breast milk. Your doctor will determine if fluoxetine is medically necessary, or if it should be discontinued while you are breastfeeding. Contact your doctor immediately if you notice that your baby is experiencing any side effects, such as sleepiness, irritability, or inability to gain weight. 

Other possible side effects:

A report described a breastfed baby who developed high blood sugar levels and high levels of sugar in the urine, which was possibly related to fluoxetine exposure.

Another report described a breastfed baby who experienced excessive sleepiness, reduced feeding, and signs of irritability, which were considered probably related to fluoxetine.

A report described a breastfed baby whose mom took fluoxetine and 2 other medications during pregnancy and while breastfeeding. The baby developed seizures and bluish skin caused by lack of oxygen in the blood.

A small study looked at 26 breastfed babies whose moms took fluoxetine while breastfeeding. The study found that the babies exposed to fluoxetine had lower weight gain.

Another study found higher serotonin levels in the blood of breastfed babies exposed to fluoxetine through breast milk. One of the breastfed babies in this study experienced delayed motor development. The study concluded that fluoxetine could affect nervous system development in breastfed babies.

A study found that babies whose moms had taken an SSRI during pregnancy and/or while breastfeeding had reduced pain sensations.

Bottom line: Fluoxetine is not recommended for use in breastfeeding moms. This medication passes into breast milk and has been associated with numerous side effects in breastfed babies, including sleepiness, irritability, loose stools, vomiting, colic, and low weight gain. Your doctor will determine if fluoxetine is medically necessary, or if it should be temporarily discontinued while breastfeeding.

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

It is possible for fluoxetine to make it harder to get pregnant. SSRIs can cause sexual dysfunction in both men and women. Some evidence has also shown that SSRIs may decrease sperm concentrations and motility, which could affect fertility in men. 

If I am taking Prozac (fluoxetine), what should I know?  

Fluoxetine should only be used during pregnancy if the benefits to the mom outweigh the potential risks to the baby. This medication crosses the placenta and can cause harm to your baby. Some studies have associated the use of fluoxetine in pregnancy with a higher risk of major birth defects, birth defects in the heart, and birth defects in the skull. Additionally, taking fluoxetine during the third trimester of pregnancy can cause your baby to be born with health problems, including breathing problems, low blood sugar levels, vomiting, and seizures.

Fluoxetine is not recommended while breastfeeding. This medication passes into breast milk and can cause side effects in your baby. Reports have described irritability, sleepiness, colic, watery stools, and sleep disturbances in babies who were exposed to fluoxetine 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 Prozac (fluoxetine) during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

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

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

Mayo Clinic: Depression (major depressive disorder)

WebMD: Major Depression (Clinical Depression)

National Institute of Mental Health: Obsessive-Compulsive Disorder

U.S. National Library of Medicine: Fluoxetine

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.