What are the side effects of Prozac (fluoxetine) during pregnancy?

From the Guidelines

Prozac (fluoxetine) during pregnancy may cause side effects, including neonatal adaptation syndrome, and should be used with caution, weighing the potential risks against the benefits of treating depression, as stopping medication can lead to relapse of depression symptoms. The most common side effects in the mother include nausea, headache, insomnia, anxiety, and decreased appetite. For the developing baby, there is a small increased risk of birth defects, particularly heart defects, when taken during the first trimester, though this risk is relatively low 1. Using Prozac in late pregnancy may lead to neonatal adaptation syndrome in newborns, causing symptoms like irritability, feeding difficulties, respiratory distress, and sometimes seizures.

Potential Risks and Benefits

• The risk of persistent pulmonary hypertension in newborns is slightly higher with long-term use of Prozac during pregnancy 1.
• Some studies suggest potential developmental effects, including delayed motor development and language acquisition, though research is ongoing 1.
• Despite these risks, untreated depression during pregnancy carries its own significant risks to both mother and baby, including poor prenatal care, substance abuse, preterm birth, and postpartum depression.
• The decision to use Prozac during pregnancy should involve weighing these potential side effects against the benefits of treating depression, as stopping medication can lead to relapse of depression symptoms.

Recommendations

• The typical dose of Prozac during pregnancy remains 20-80 mg daily, with the lowest effective dose preferred 1.
• Clinicians should be aware that infants are at risk for manifesting clinical signs of drug toxicity or withdrawal over the first week of life and arrange for early follow-up after the initial hospital discharge 1.
• Women with a history of severe suicide attempts or severe depression who have previously experienced symptom reduction with antidepressant treatment may respond to antidepressants better than psychotherapy 1.
• The American Psychiatric Association and the American College of Obstetricians and Gynecologists have published recommendations about decision-making regarding antidepressant treatment during pregnancy, suggesting that antidepressants may be a superior treatment option to psychotherapy for some women 1.

From the FDA Drug Label

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. Such complications can arise immediately upon delivery Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN)

The side effects of Prozac (fluoxetine) during pregnancy include:

• Respiratory complications: respiratory distress, cyanosis, apnea
• Neurological complications: seizures, temperature instability, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability
• Gastrointestinal complications: feeding difficulty, vomiting
• Increased risk of persistent pulmonary hypertension of the newborn (PPHN) 2 2

From the Research

Side Effects of Prozac (Fluoxetine) During Pregnancy

• The use of selective serotonin reuptake inhibitors (SSRIs), including fluoxetine, during pregnancy has been associated with several potential risks, including persistent pulmonary hypertension of the newborn and a self-limiting neonatal behavioral syndrome 3.
• Some studies have suggested a relationship between the use of SSRIs, such as fluoxetine, and the occurrence of miscarriage, although these studies had methodologic limitations that affected the strength of the data 3.
• Antidepressant exposure during pregnancy, including fluoxetine, has been associated with an increased risk of autism spectrum disorder (ASD) in the offspring, although the risk is decreased after adjusting for confounding variables and is mostly no longer statistically significant after adjusting for maternal mental illness 4.
• The use of SSRIs, including fluoxetine, during pregnancy may be associated with an increased risk of several complications, including preterm birth, neonatal complications, and congenital malformations, although the absolute risk is small 5, 6.
• It is not clear how much of the increased pathology seen in women using antidepressants during pregnancy and their newborns is due to drug use or underlying pathology 6.

Considerations for Use

• SSRIs, including fluoxetine, can still be considered as appropriate for use in pregnant or lactating women who require a pharmacological treatment, as the abundant data support their relative safety 5.
• The potential risks associated with untreated depression, including adverse effects on pregnancy outcome and infant well-being, should be weighed against the potential risks associated with SSRI use 7, 5.
• Careful follow-up of infants exposed to SSRIs, including fluoxetine, in utero is recommended 3.