Sertraline Pregnancy and Breastfeeding Warnings

Sertraline is also known as: Zoloft

Sertraline Pregnancy Warnings

A case of suspected neonatal withdrawal symptoms, secondary to maternal use of sertraline throughout pregnancy has been reported. The neonate developed symptoms of agitation, restlessness, poor feeding, constant crying, insomnia and an enhanced startle reaction. The results of a cohort study indicate that 30% of neonates who had prolonged exposure to SSRIs in utero experience symptoms, in a dose- response manner, of a neonatal abstinence syndrome (e.g., tremor, gastrointestinal or sleep disturbances, hypertonicity, high- pitched cry) after birth. The authors suggest that infants exposed to SSRIs should be closely monitored for a minimum of 48 hours after birth. The effect of sertraline on labor and delivery in humans is unknown.

Sertraline has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity, but have revealed decreased pup survival related to in utero sertraline exposure in doses up to 4 times the maximum human recommended dose. There are no controlled data in human pregnancy. Neonates exposed to sertraline late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. 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. These symptoms are consistent with either a direct toxic effect of SSRIs, a drug discontinuation syndrome, or possible serotonin syndrome. Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). This condition has been associated with substantial neonatal morbidity and mortality. It has not been determined if all SSRIs pose a similar level of PPHN risk. Sertraline is only recommended for use during pregnancy when benefit outweighs risk.

Sertraline Breastfeeding Warnings

Sertraline is excreted into human milk. Adverse effects in the nursing infant are unlikely. The manufacturer recommends that caution be used when administering sertraline to nursing women.

A study of fourteen mother- infant pairs reported that while mothers receiving clinical doses of sertraline experienced substantial blockade of the platelet 5-HT transporter, platelet 5-HT uptake in nursing infants of treated mothers was unaltered. Another study of twelve breast-feeding mothers reported that both sertraline and desmethylsertraline were present in all breast milk samples. Detectable levels of sertraline were reported in three nursing infants and detectable levels of desmethylsertraline were reported in six infants. The data from one study on three breast- fed infants suggested that sertraline and/or its almost inactive metabolite norsertraline may be present at very low concentrations in the plasma of breast- fed infants. No adverse effects were noted in the infants. A case study of a mother breast-feeding while receiving sertraline therapy has also been reported. The drug was found to be present in the mother's milk. However, no sertraline was detected in the infant's serum and no abnormal occurrences were noted in the development of this infant either.

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