Can I take pregabalin while pregnant or breastfeeding?

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. To provide information regarding the effects of in utero exposure to pregabalin, physicians are advised to recommend that pregnant patients taking pregabalin enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/ . Risk Summary Observational studies on the use of pregabalin during pregnancy suggest a possible small increase in the rate of overall major birth defects, but there was no consistent or specific pattern of major birth defects identified (see Data) . Available postmarketing data on miscarriage and other maternal, fetal, and long term developmental adverse effects were insufficient to identify risk associated with pregabalin.

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

Limited data indicate that amounts of pregabalin in breastmilk are low and one infant breastfed for 3 months with no discernable adverse effects. Pharmacokinetic model predicted that a maternal dosage of 150 mg daily would not result in a therapeutic level in an exclusively breastfed infant of any age. If pregabalin is required by the mother, it is not a reason to discontinue breastfeeding, but until more data become available, use caution while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding is not recommended during treatment with pregabalin because of the potential risk of tumorigenicity based on high-dose animal studies over a prolonged period. Pregabalin has been used to treat persistent nipple pain in a few women at an average starting dosage of 100 mg daily.[1]

“Summary of Use during Lactation”, LactMed record “Pregabalin” (LM908), quoted verbatim. Everything LactMed reports about Pregabalin while breastfeeding.

8.2 Lactation Risk Summary Small amounts of pregabalin have been detected in the milk of lactating women. A pharmacokinetic study in lactating women detected pregabalin in breast milk at average steady state concentrations approximately 76% of those in maternal plasma. The estimated average daily infant dose of pregabalin from breast milk (assuming mean milk consumption of 150 mL/kg/day) was 0.31 mg/kg/day, which on a mg/kg basis would be approximately 7% of the maternal dose ( see Data) . The study did not evaluate the effects of pregabalin on milk production or the effects of pregabalin on the breastfed infant. Based on animal studies, there is a potential risk of tumorigenicity with pregabalin exposure via breast milk to the breastfed infant [see Nonclinical Toxicology ( 13.1 )] . Available clinical study data in patients greater than 12 years of age do not provide a clear conclusion about the potential risk of tumorigenicity with pregabalin [see Warnings and Precautions ( 5.9 )] . Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.

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