Is fluoxetine (Prozac) safe during pregnancy?

From the Guidelines

Fluoxetine can be used during pregnancy when the benefits outweigh the risks, but it is not completely without concerns. It is generally considered one of the safer antidepressant options for pregnant women who need treatment for depression or anxiety. The typical adult dose is 20-80 mg daily. If you're currently taking fluoxetine and become pregnant, don't stop taking it suddenly as this could lead to withdrawal symptoms and worsening depression. Some studies suggest a small increased risk of birth defects, particularly heart defects, when fluoxetine is used in the first trimester, though the absolute risk remains low 1. There may also be a slight risk of persistent pulmonary hypertension in newborns when SSRIs like fluoxetine are used late in pregnancy. Babies exposed to fluoxetine near delivery might experience temporary withdrawal symptoms such as irritability, feeding difficulties, or respiratory issues.

Key Considerations

• The decision to use fluoxetine during pregnancy should be made together with your healthcare provider, weighing your mental health needs against potential risks to the developing baby.
• Untreated depression during pregnancy carries its own significant risks for both mother and baby, including poor prenatal care, substance use, preterm birth, and postpartum depression.
• Research has shown that prenatal antidepressant exposure does not substantially increase the risk for two concerning neurodevelopmental problems -- ASD and ADHD 1.
• Other factors, such as maternal indications for antidepressant use, may contribute to an increased likelihood for the exposed offspring to develop neurodevelopmental problems 1.

Recommendations

• Women with mild depression with a recent onset should be monitored and encouraged to exercise and seek social support.
• Women with mild depression that does not improve within two weeks of diagnosis and women with moderate–to–severe depression should seek/be offered evidence-based treatment, which may include fluoxetine.
• The American Psychiatric Association and the American College of Obstetricians and Gynecologists recommend that antidepressants may be a superior treatment option to psychotherapy for some women, particularly those with a history of severe suicide attempts or severe depression who have previously experienced symptom reduction with antidepressant treatment 1.

From the FDA Drug Label

Pregnancy Category C In embryo–fetal development studies in rats and rabbits, there was no evidence of teratogenicity following administration of up to 12.5 and 15 mg/kg/day, respectively (1.5 and 3. 6 times, respectively, the MRHD of 80 mg on a mg/m2 basis) throughout organogenesis. However, in rat reproduction studies, an increase in stillborn pups, a decrease in pup weight, and an increase in pup deaths during the first 7 days postpartum occurred following maternal exposure to 12 mg/kg/day (1.5 times the MRHD on a mg/m2 basis) during gestation or 7.5 mg/kg/day (0. 9 times the MRHD on a mg/m2 basis) during gestation and lactation. Prozac should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus Neonates exposed to Prozac and other SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN)

Key Considerations:

• Pregnancy Category C: Fluoxetine may be used in pregnancy, but only if the potential benefits outweigh the potential risks.
• Potential Risks: Increased risk of stillborn pups, decreased pup weight, and increased pup deaths in rat studies; complications in neonates, including respiratory distress and persistent pulmonary hypertension of the newborn (PPHN).
• Recommendation: Use fluoxetine during pregnancy only if the potential benefit justifies the potential risk to the fetus 2.

From the Research

Safety of Fluoxetine in Pregnancy

• The safety of fluoxetine in pregnancy is a topic of ongoing research and debate 3, 4, 5, 6, 7.
• Studies have shown that fluoxetine, a selective serotonin reuptake inhibitor (SSRI), can cross the placenta and expose the fetus directly to the drug, as well as affect the mother's physiology, which can have implications for fetal development 3.
• Clinical studies suggest poor neonatal outcomes after exposure to fluoxetine in utero, including reduced growth and increased risk of preterm delivery 3, 4.
• Some studies have raised concerns about the potential increased risk of fetal cardiovascular malformation associated with in utero exposure to fluoxetine 4.
• However, other studies have found that fluoxetine may be beneficial in reducing stress-induced anxiety- and depressive-like behavior in pregnant and postpartum dams, but with dose-dependent effects on the offspring 5.
• The current evidence suggests that the use of fluoxetine during pregnancy should be carefully considered and monitored, taking into account the potential risks and benefits for both the mother and the fetus 3, 4, 6.
• Further research is needed to fully understand the impact of fluoxetine on fetal development and to determine the safest and most effective treatment options for pregnant women with depression 3, 5, 7.

Key Findings

• Fluoxetine can cross the placenta and expose the fetus directly to the drug 3.
• In utero exposure to fluoxetine may be associated with poor neonatal outcomes, including reduced growth and increased risk of preterm delivery 3, 4.
• Fluoxetine may be beneficial in reducing stress-induced anxiety- and depressive-like behavior in pregnant and postpartum dams, but with dose-dependent effects on the offspring 5.
• The use of fluoxetine during pregnancy should be carefully considered and monitored, taking into account the potential risks and benefits for both the mother and the fetus 3, 4, 6.

Implications for Clinical Practice

• Healthcare providers should carefully weigh the potential risks and benefits of fluoxetine use during pregnancy 3, 4, 6.
• Pregnant women with depression should be closely monitored and managed to minimize the risks associated with fluoxetine use 3, 4, 6.
• Further research is needed to determine the safest and most effective treatment options for pregnant women with depression 3, 5, 7.