Can I take sertraline while pregnant or breastfeeding?

Pregnancy Teratogenic Effects 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. These doses correspond to approximately 4 times the maximum recommended human dose (MRHD) on a mg/m 2 basis. 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/m 2 basis) in rats and 40 mg/kg (4 times the MRHD on a mg/m 2 basis) in rabbits. When female rats received sertraline during the last third of gestation and throughout lactation, there was an increase in the number of stillborn pups and in the number of pups dying during the first 4 days after birth. Pup body weights were also decreased during the first four days after birth. These effects occurred at a dose of 20 mg/kg (1 times the MRHD on a mg/m 2 basis). The no effect dose for rat pup mortality was 10 mg/kg (0.5 times the MRHD on a mg/m 2 basis). The decrease in pup survival was shown to be due to in utero exposure to sertraline.

Prescribing label, section “Pregnancy” (opening excerpt): Sertraline Hydrochloride (oral), Quality Care Products LLC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Because of the low levels of sertraline in breastmilk, amounts ingested by the infant are small and is usually not detected in the serum of the infant, although the weakly active metabolite norsertraline (desmethylsertraline) is often detectable in low levels in infant serum. Rarely, preterm infants with impaired metabolic activity might accumulate the drug and demonstrate symptoms similar to neonatal abstinence. No adverse effects on development have been found in infants followed for up to 5 years of age. Most authoritative reviewers consider sertraline a preferred antidepressants during breastfeeding.[1-9]

Mothers taking an SSRI during pregnancy and postpartum may have more difficulty breastfeeding, although this might be a reflection of their disease state.[10] These mothers may need additional breastfeeding support. Breastfed infants exposed to an SSRI during the third trimester of pregnancy are at risk for neonatal withdrawal syndrome consisting of hypoglycemia, tremors, tachycardia, or hypotonia, and might be at a greater risk of readmission due to jaundice.[11,12]

“Summary of Use during Lactation”, LactMed record “Sertraline” (LM328), quoted verbatim. Everything LactMed reports about Sertraline while breastfeeding.

Nursing Mothers It is not known whether, and if so in what amount, sertraline or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sertraline hydrochloride is administered to a nursing woman.

Prescribing label, section “Nursing Mothers”: Sertraline Hydrochloride (oral), Quality Care Products LLC. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.