Can I take paroxetine while pregnant or breastfeeding?

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including paroxetine, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Antidepressants 1-866- 961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/ pregnancyregistry/antidepressants/. Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.5) and Clinical Considerations]. Paroxetine is associated with a less than 2-fold increase in cardiovascular malformations when administered to a pregnant woman during the first trimester. While individual epidemiological studies on the association between paroxetine use and cardiac malformations have reported inconsistent findings, some meta-analyses of epidemiological studies have identified an increased risk of cardiovascular malformations (see Data) .

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Paroxetine (oral), REMEDYREPACK INC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Because of the low levels of paroxetine in breastmilk, amounts ingested by the infant are small and paroxetine has not been detected in the serum of most infants tested. Occasional mild side effects have been reported, especially in the infants of mothers who took paroxetine during the third trimester of pregnancy, but the contribution of the drug in breastmilk is not clear. . No adverse effects on development have been found in infants followed for up to 5 years of age. Most authoritative reviewers consider paroxetine one of the preferred antidepressants during breastfeeding.[1-7] Monitor breastfed infants for excess sedation, agitation, irritability, poor feeding and poor weight gain

Mothers taking an SSRI during pregnancy and postpartum may have more difficulty breastfeeding, although this might be a reflection of their disease state.[8] 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.[9,10]

“Summary of Use during Lactation”, LactMed record “Paroxetine” (LM327), quoted verbatim. Everything LactMed reports about Paroxetine while breastfeeding.

8.2 Lactation Risk Summary Data from the published literature report the presence of paroxetine in human milk (see Data) . There are reports of agitation, irritability, poor feeding and poor weight gain in infants exposed to paroxetine through breast milk (see Clinical Considerations) . There are no data on the effect of paroxetine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for paroxetine and any potential adverse effects on the breastfed child from paroxetine or from underlying maternal condition.

Prescribing label, section “8.2 Lactation” (opening excerpt): Paroxetine (oral), REMEDYREPACK INC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.