Is sertraline (Zoloft) safe during pregnancy?

From the Guidelines

Sertraline can be used during pregnancy when the benefits outweigh the risks, but it should be taken only under medical supervision. According to the most recent and highest quality study, a critical review of maternal antidepressant use during pregnancy and offspring neurodevelopmental problems suggests that intrauterine antidepressant exposure does not substantially increase the risk for neurodevelopmental problems such as ASD and ADHD 1. The study emphasizes the importance of considering a wide variety of potential consequences for offspring development, including adverse birth outcomes and neurodevelopmental problems.

Key Considerations

• The research to date should provide women considering antidepressant use during pregnancy reassurance, as the risks associated with sertraline are relatively low compared to the potential harm of untreated maternal depression 1.
• Pregnant women taking sertraline should be aware of possible neonatal adaptation syndrome in newborns, which may cause temporary breathing difficulties, irritability, or feeding problems after birth 1.
• Women should never stop taking sertraline suddenly during pregnancy as this could lead to withdrawal symptoms and worsening depression.
• Any woman who is pregnant or planning pregnancy while on sertraline should discuss her specific situation with her healthcare provider to create an appropriate treatment plan that balances mental health needs with pregnancy considerations.

Treatment Decisions

• The typical dosage of sertraline ranges from 50-200 mg daily, with treatment decisions made on an individual basis by healthcare providers.
• 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.
• Experts have recommended a stepped approach to treatment of depression during pregnancy, with women with mild depression being monitored and encouraged to exercise and seek social support, and women with moderate-to-severe depression seeking evidence-based treatment 1.

From the FDA Drug Label

There are no adequate and well-controlled studies in pregnant women. Sertraline hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus Pregnancy-Nonteratogenic Effects Neonates exposed to sertraline 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 pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). When treating a pregnant woman with sertraline, the physician should carefully consider both the potential risks of taking an SSRI, along with the established benefits of treating depression with an antidepressant. The decision can only be made on a case by case basis

Sertraline use during pregnancy is not without risks. The potential benefits of using sertraline during pregnancy must be weighed against the potential risks to the fetus, including:

• Increased risk of persistent pulmonary hypertension of the newborn (PPHN)
• Complications in neonates, such as respiratory distress, cyanosis, apnea, seizures, and temperature instability
• Potential for serotonin syndrome The decision to use sertraline during pregnancy should be made on a case-by-case basis, considering the individual patient's circumstances and the potential risks and benefits 2, 2.

From the Research

Safety of Sertraline During Pregnancy

• The study published in the European journal of clinical pharmacology 3 found that sertraline concentrations in pregnant women are steady and the drug transfer to their infants is low, with only mild and transient adverse effects seen on the infants.
• A literature review published in Psychiatria Danubina 4 suggested that sertraline and citalopram should be first-line drug treatments for anxiety and depression in pregnant women in the SSRI class, as they have a lower association with negative outcomes compared to other SSRIs.
• A population-based cohort study published in the American journal of obstetrics and gynecology 5 found that sertraline use during pregnancy was associated with an increased risk of atrial/ventricular defects and craniosynostosis, but not with an overall increased risk of major malformations.
• Another study published in The Australian and New Zealand journal of psychiatry 6 found that sertraline was effective in reducing symptoms of depression and anxiety in postpartum women, although cognitive behavioural therapy (CBT) was found to be superior to sertraline in this population.
• A systematic review and meta-analysis published in Clinical psychology review 7 found that CBT was effective for perinatal maternal depression, anxiety, and stress, but did not specifically address the safety of sertraline during pregnancy.

Key Findings

• Sertraline has a low transfer rate to infants and is generally considered safe during pregnancy, although it may be associated with an increased risk of certain congenital malformations 3, 5.
• Sertraline is considered a first-line treatment for anxiety and depression in pregnant women, along with citalopram 4.
• CBT is a effective treatment for perinatal maternal depression, anxiety, and stress, and may be a viable alternative to sertraline for some women 6, 7.