Is Prozac Safe During Pregnancy?
Prozac (fluoxetine) is one of the oldest and most widely used SSRI antidepressants. According to MotherToBaby, fluoxetine is not expected to increase the chance of birth defects, and there is no proven increased chance of birth defects directly related to it.
It is not one of the two SSRIs the American College of Obstetricians and Gynecologists (ACOG) names as first choices for people who have never taken an antidepressant. But ACOG says a medication that has already worked for you should generally be the choice, and that concerns about fluoxetine should not stop its use if it has been effective. For the full comparison, see antidepressants during pregnancy.
Prozac and Birth Defects
About 3 in 100 babies have a birth defect regardless of medication.
- In a U.S. study of nearly 950,000 pregnancies, heart defects occurred in about 90 per 10,000 fluoxetine-exposed babies compared with 72 per 10,000 unexposed babies. Across SSRIs, that difference shrank to nearly nothing once depression itself was accounted for.
- A CDC birth defects study reported possible links between early-pregnancy fluoxetine and two specific defects, and a meta-analysis found a small increase in heart defects. But when that meta-analysis compared only women who had a psychiatric diagnosis, the increase was not statistically significant.
These findings are contested, and the evidence overall does not show that fluoxetine causes birth defects.
Other Pregnancy Risks
- Miscarriage: a small number of studies did not find a greater chance of miscarriage.
- Preterm birth and low birth weight: some studies suggest a higher chance, which is hard to separate from depression itself.
- PPHN (a rare newborn lung condition): the overall chance with SSRIs is under 1%.
- Newborn adaptation symptoms: this is the main fluoxetine-specific concern. Because fluoxetine and its active breakdown product last a long time in the body, it has been linked more often to temporary newborn symptoms such as jitteriness, irritability or feeding trouble. In most cases symptoms are mild and go away in a few weeks with little or no treatment. Stopping before delivery is not recommended.
- Development: studies following children from 16 months to 7 years did not find differences between those exposed to fluoxetine in pregnancy and those who were not.
Is Prozac Category C?
Prozac was labeled “Pregnancy Category C.” The FDA removed all pregnancy letter categories from drug labels in 2015 because they were confusing and overly simplistic. Zoloft, Lexapro and Wellbutrin were Category C too, so the letter did not rank their safety.
Should You Keep Taking Prozac If You Get Pregnant?
- ACOG recommends against stopping mental health medication because of pregnancy alone.
- If fluoxetine has been effective for you, ACOG says its known issues should not prevent you from continuing it.
- In a study of women with prior major depression, 68% of those who stopped antidepressants during pregnancy relapsed, compared with 26% who continued.
- Do not stop suddenly. Plan any change with your prescriber.
Fluoxetine is also FDA-approved for premenstrual dysphoric disorder under the brand name Sarafem; see PMDD treatment. People with PMDD have a higher risk of postpartum depression.
Prozac and Breastfeeding
According to the NIH’s LactMed database, fluoxetine is not a reason to stop breastfeeding, but it passes into breast milk in higher amounts than most other SSRIs.
- An exclusively breastfed baby receives an estimated 2.4% of the mother’s weight-adjusted dose; including its long-acting breakdown product, estimates average around 5% to 7%.
- The breakdown product, norfluoxetine, is detectable in most breastfed babies early on.
- Colic, fussiness and drowsiness have been reported in some breastfed babies, and one study found slower weight gain, though other studies did not.
- No developmental harm has been found in children followed for up to 5 years.
- LactMed advises watching the baby for colic, agitation, irritability, poor feeding and poor weight gain.
If You Took Prozac During Pregnancy
This is the most important point for fluoxetine. If you took fluoxetine during pregnancy, most experts recommend against changing medications for breastfeeding, according to LactMed, and ACOG agrees that a medication that kept you stable should not be changed after birth. Your baby’s exposure during pregnancy was far greater than exposure through breast milk.
If you are starting an antidepressant for the first time while breastfeeding, especially with a newborn or preterm baby, an SSRI that passes into milk less, such as sertraline, may be preferred. You do not need to pump and dump.
Talk to Your Prescriber
Find a perinatal mental health therapist
If you have thoughts of harming yourself, call or text 988, or call or text the National Maternal Mental Health Hotline at 1-833-TLC-MAMA (1-833-852-6262).
Frequently Asked Questions
Is Prozac safe during pregnancy?
Fluoxetine is not expected to increase the chance of birth defects. It has been linked more often to temporary newborn symptoms, but ACOG says that should not prevent its use if it has worked for you.
Does Prozac cause birth defects?
There is no proven increased risk. Some studies reported possible links that were not significant when limited to women with a psychiatric diagnosis.
What pregnancy category is Prozac?
It was formerly Category C. The FDA removed letter categories in 2015.
Can you take Prozac while breastfeeding?
Yes. LactMed says it is not a reason to stop breastfeeding, though more reaches the baby than with most SSRIs, so watch for colic, fussiness or poor weight gain.
Should I switch from Prozac to Zoloft after birth?
If fluoxetine kept you well during pregnancy, most experts recommend not switching for breastfeeding.
