Is sertraline (selective serotonin reuptake inhibitor) safe to use during pregnancy?

Sertraline Safety in Pregnancy

Sertraline should be considered first-line therapy for depression and anxiety during pregnancy and can be safely continued throughout gestation at the lowest effective dose, as the benefits of treating maternal depression substantially outweigh the minimal risks to the fetus. 1

Primary Recommendation

• Continue sertraline during pregnancy rather than discontinuing it, as withdrawal of medication may have harmful effects on the mother-infant dyad. 1, 2
• Use the lowest effective dose throughout all trimesters to minimize fetal exposure while maintaining maternal mental health. 1, 3
• The American Academy of Pediatrics specifically recommends sertraline as first-line therapy due to its favorable safety profile and minimal excretion in breast milk. 1

Fetal Safety Profile

Structural Malformations

• Large population-based studies have demonstrated no increased risk of cardiac malformations with first-trimester sertraline use. 1
• This contrasts with paroxetine, which carries FDA pregnancy category D classification due to cardiac malformation concerns and should be avoided. 1, 4

Neurodevelopmental Outcomes

• Multiple recent reviews have not identified adverse neurodevelopmental outcomes among infants born to women treated with sertraline during pregnancy. 1, 2

Neonatal Risks and Management

Neonatal Adaptation Syndrome

• Approximately one-third of newborns exposed to sertraline in late pregnancy may develop transient neonatal adaptation syndrome. 3
• Symptoms include irritability, jitteriness, tremors, feeding difficulty, sleep disturbance, respiratory distress, hypoglycemia, and rarely seizures. 1, 3, 2
• These symptoms typically appear within hours to days after birth and usually resolve spontaneously within 1-2 weeks without long-term sequelae. 1, 3, 2

Persistent Pulmonary Hypertension of the Newborn (PPHN)

• There is a possible association between late pregnancy SSRI exposure and PPHN, with a number needed to harm of 286-351. 1, 2
• This represents an absolute risk increase of approximately 0.3-0.4%, which must be weighed against the substantial risks of untreated maternal depression. 1

Monitoring Protocol

• Infants exposed to sertraline in utero should be monitored for at least 48 hours after birth for signs of adaptation syndrome. 3, 2
• Arrange early follow-up after initial hospital discharge to monitor for any delayed symptoms over the first week of life. 1, 3
• Inform the pediatric team about maternal sertraline use so they can anticipate and manage neonatal adaptation syndrome if it occurs. 2
• In severely affected infants with persistent symptoms, a short-term course of chlorpromazine has provided measurable relief. 1, 3

Risks of Untreated Depression

• Untreated depression during pregnancy carries significant documented risks including premature birth, decreased breastfeeding initiation, and harm to the mother-infant relationship. 1, 2
• Women who discontinue antidepressant medication during pregnancy show a significant increase in relapse of major depression. 5
• The risks of untreated maternal depression substantially outweigh the minimal risks associated with sertraline exposure. 1

Dosing Considerations

• Start with standard doses (50-100 mg daily for extensive metabolizers) and titrate to the lowest effective dose. 1
• Sertraline pharmacokinetics change during pregnancy due to maternal volume expansion and reduced plasma albumin, potentially requiring dose adjustments. 6
• Trough plasma concentrations may decrease throughout gestation, and some patients may require dose increases in the second and third trimesters to maintain therapeutic effect. 6
• The FDA label notes that sertraline crosses the placenta and can be found in amniotic fluid. 3, 5

Postpartum and Breastfeeding

• Sertraline is minimally excreted in breast milk, providing the infant with less than 10% of the maternal daily dose, and should be continued during breastfeeding. 1, 3
• Sertraline and paroxetine are the most commonly prescribed antidepressants during breastfeeding and are considered suitable first-line agents. 1
• Infant plasma concentrations are approximately 25-33% of maternal concentrations, with low risk of adverse effects. 7
• Women already taking sertraline should continue both the medication and breastfeeding, as the benefits of both are well-documented. 1

Clinical Decision Algorithm

When a pregnant woman requires antidepressant treatment:

• Choose sertraline as first-line SSRI therapy due to its established safety profile. 1, 8
• If sertraline is not tolerated or ineffective, consider citalopram as an alternative. 1, 8
• Avoid paroxetine specifically due to cardiac malformation concerns. 1, 4
• Use the lowest effective dose throughout pregnancy and continue treatment rather than discontinuing. 1, 2

For women already taking sertraline who become pregnant:

• Continue sertraline at the current effective dose rather than discontinuing or switching medications. 2, 5
• Monitor for adequate symptom control throughout pregnancy and adjust dose if needed. 6
• Coordinate with pediatrics for neonatal monitoring in the first 48 hours after delivery. 3, 2

Common Pitfalls to Avoid

• Do not discontinue sertraline due to fear of medication risks, as untreated maternal depression carries substantial documented risks to both mother and infant. 1
• Do not abruptly stop sertraline if discontinuation is deemed necessary; taper gradually to minimize withdrawal symptoms in both mother and fetus. 5
• Do not switch from sertraline to another SSRI without clear clinical indication, as this introduces uncertainty about the safety profile of the new medication. 8
• Do not avoid breastfeeding due to sertraline use, as the drug transfers in very low concentrations and the benefits of breastfeeding are substantial. 1, 7