From the Guidelines
Zoloft (sertraline) can be used during pregnancy, but the decision should be made after weighing the benefits of treating maternal depression against potential risks to the developing baby, and it is recommended to continue the medication at the lowest effective dose 1. The use of Zoloft during pregnancy involves considering the potential risks and benefits, including the risk of neonatal adaptation syndrome, which can manifest as continuous crying, irritability, jitteriness, and/or restlessness; shivering; fever; tremors; hypertonia or rigidity; tachypnea or respiratory distress; feeding difficulty; sleep disturbance; hypoglycemia; and seizures 1. However, recent research suggests that intrauterine antidepressant exposure does not substantially increase the risk for neurodevelopmental problems, such as autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) 1. Key factors to consider when making a decision about Zoloft use during pregnancy include:
- The severity of current symptoms
- Previous mental health history
- Patient treatment preferences
- The potential risks and benefits of treatment alternatives It is essential to work with a healthcare provider to make an informed decision about Zoloft use during pregnancy, taking into account individual circumstances and the latest research findings 1. Some important considerations for pregnant women taking Zoloft include:
- The risk of persistent pulmonary hypertension of the newborn
- The potential for neonatal adaptation syndrome
- The importance of not stopping the medication abruptly, as this could worsen depression symptoms
- The need for close monitoring and follow-up with a healthcare provider to discuss any concerns or questions 1.
From the FDA Drug Label
Treatment of Pregnant Women During the Third Trimester Neonates exposed to sertraline and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding When treating pregnant women with sertraline during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. Pregnancy-Pregnancy Category C Reproduction studies have been performed in rats and rabbits at doses up to 80 mg/kg/day and 40 mg/kg/day, respectively There was no evidence of teratogenicity at any dose level. When pregnant rats and rabbits were given sertraline during the period of organogenesis, delayed ossification was observed in fetuses at doses of 10 mg/kg (0. 5 times the MRHD on a mg/m2 basis) in rats and 40 mg/kg (4 times the MRHD on a mg/m2 basis) in rabbits. 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).
Key Points:
- Potential Risks: Neonates exposed to sertraline in the third trimester may develop complications.
- Benefits and Risks: The physician should carefully consider the potential benefits and risks of treatment with sertraline during pregnancy.
- Pregnancy Category: Sertraline is classified as Pregnancy Category C, meaning there are no adequate and well-controlled studies in pregnant women.
- Teratogenicity: There was no evidence of teratogenicity at any dose level in reproduction studies.
- Use in Pregnancy: Sertraline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The use of Zoloft (sertraline) during pregnancy should be approached with caution, considering the potential risks and benefits. The decision to use sertraline during pregnancy can only be made on a case-by-case basis 2 2.
From the Research
Zoloft (Sertraline) Use in Pregnancy
- Zoloft, also known as sertraline, is a selective serotonin reuptake inhibitor (SSRI) commonly used to treat depression and other mental health conditions.
- The safety of using Zoloft during pregnancy has been studied in several research papers, with some indicating a potential increased risk of persistent pulmonary hypertension in the newborn (PPHN) 3, 4, 5, 6.
- A study published in 2006 found that maternal use of SSRIs in late pregnancy was associated with an increased risk of PPHN in the offspring, with an adjusted odds ratio of 6.1 3.
- Another study published in 2012 found that exposure to SSRIs in late pregnancy was associated with an increased risk of PPHN, with an absolute risk of 3 per 1000 liveborn infants 4.
- A systematic review and meta-analysis published in 2019 found that exposure to SSRIs during pregnancy was associated with an increased risk of PPHN, with an odds ratio of 1.82, and that sertraline was ranked as having the lowest risk among the different SSRIs 5.
- A narrative review published in 2023 noted that SSRIs, including sertraline, are considered relatively safe during pregnancy, but that each clinical situation should be evaluated with caution 7.
- A meta-analysis published in 2014 found that exposure to SSRIs in late pregnancy was associated with an increased risk of PPHN, with an odds ratio of 2.50, but that the absolute risk remained low 6.
Key Findings
- The use of Zoloft (sertraline) during pregnancy may be associated with an increased risk of PPHN in the newborn.
- The risk of PPHN is higher when SSRIs, including sertraline, are used in late pregnancy.
- Sertraline may have a lower risk of PPHN compared to other SSRIs.
- The absolute risk of PPHN remains low, even with exposure to SSRIs in late pregnancy.
- Each clinical situation should be evaluated with caution, taking into account individual patient characteristics and the severity of the disorder. 3, 4, 5, 7, 6