Can I take liraglutide while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide during pregnancy. Liraglutide injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies identified increased adverse developmental outcomes from exposure during pregnancy. Liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 1.8 mg/day. In pregnant rabbits administered liraglutide during organogenesis, decreased fetal weight and an increased incidence of major fetal abnormalities were seen at exposures below the human exposures at the MRHD ( see Animal Data) . The estimated background risk of major birth defects for women with uncontrolled pre-gestational diabetes (Hemoglobin A 1c >7) is 6 to 10%. The major birth defect rate has been reported to be as high as 20 to 25% in women with a Hemoglobin A 1c >10.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Liraglutide (subcutaneous), Meitheal Pharmaceuticals Inc. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

This quote is from the subcutaneous formulation label.

No information is available on the use of liraglutide during breastfeeding. Because liraglutide is a large peptide molecule with a molecular weight of 3751 daltons, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, liraglutide should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Some experts recommend closely monitoring of infant growth and developmental milestones and the nutritional status of the lactating woman.[1]

“Summary of Use during Lactation”, LactMed record “Liraglutide” (LM1380), quoted verbatim. Everything LactMed reports about Liraglutide while breastfeeding.

8.2 Lactation Risk Summary There are no data on the presence of liraglutide in human milk, the effects on the breastfed infant, or the effects on milk production. Liraglutide was present in milk of lactating rats ( see Data) . Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for liraglutide injection and any potential adverse effects on the breastfed infant from liraglutide or from the underlying maternal condition. Data In lactating rats, liraglutide was present unchanged in milk at concentrations approximately 50% of maternal plasma concentrations.

Prescribing label, section “8.2 Lactation”: Liraglutide (subcutaneous), Meitheal Pharmaceuticals Inc. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

This quote is from the subcutaneous formulation label.