Can I take duloxetine while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage. Data from published literature and from a postmarketing retrospective cohort study have not identified a clear drug-associated risk of major birth defects or other adverse developmental outcomes (see Data) . There are risks associated with untreated depression and fibromyalgia in pregnancy, and with exposure to SNRIs and SSRIs, including duloxetine delayed-release capsules, during pregnancy (see Clinical Considerations) . In rats and rabbits treated with duloxetine during the period of organogenesis, fetal weights were decreased but there was no evidence of developmental effects at doses up to 3 and 6 times, respectively, the maximum recommended human dose (MRHD) of 120 mg/day given to adolescents on a mg/m 2 basis. When duloxetine was administered orally to pregnant rats throughout gestation and lactation, pup weights at birth and pup survival to 1 day postpartum were decreased at a dose 2 times the MRHD given to adolescents on a mg/m 2 basis.

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

Little published information is available on the use of duloxetine during breastfeeding; however, the dose in milk is low and serum levels were low in two breastfed infants. If the mother requires duloxetine, it is not a reason to discontinue breastfeeding. Expert opinion finds duloxetine acceptable to use during breastfeeding,[1] and a safety scoring system finds duloxetine use to be possible to use cautiously during breastfeeding.[2] An alternate drug that has been better studied may be preferred, especially while nursing a newborn or preterm infant. Monitor the infant for drowsiness and adequate feeding, weight gain and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of psychotropic drugs. Galactorrhea has been reported in women taking duloxetine.

“Summary of Use during Lactation”, LactMed record “Duloxetine” (LM585), quoted verbatim. Everything LactMed reports about Duloxetine while breastfeeding.

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

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