Can I take buprenorphine for pain while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary The data on use of buprenorphine, the active ingredient in Buprenorphine Sublingual Tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. There are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see Data ] . Observational studies have reported on congenital malformations among buprenorphine- exposed pregnancies, but were also not designed appropriately to assess the risk of congenital malformations specifically due to buprenorphine exposure [see Data ] . Reproductive and developmental studies in rats and rabbits identified adverse events at clinically relevant and higher doses. Embryofetal death was observed in both rats and rabbits administered buprenorphine during the period of organogenesis at doses approximately 6 and 0.3 times, respectively, the human sublingual dose of 16 mg/day of buprenorphine.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): buprenorphine hydrochloride (sublingual), Advagen Pharma Ltd. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

This quote is from the sublingual formulation label.

Because of the low levels of buprenorphine in breastmilk, its poor oral bioavailability in infants, and the low drug concentrations found in the serum and urine of breastfed infants, its use is acceptable in nursing mothers, including long-acting forms. Monitor the infant for drowsiness, respiratory depression, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants. Although unlikely, if the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breastfeeding is stopped.

Women who received buprenorphine for opiate abuse during pregnancy and are stable should be encouraged to breastfeed their infants postpartum, unless there is another contraindication, such as use of street drugs.[1-12] Women receiving antenatal buprenorphine or buprenorphine-naloxone are more likely to initiate breastfeeding postpartum than those receiving methadone.[13] The long-term outcome of infants breastfed during maternal buprenorphine therapy for opiate abuse has not been well studied.[14] The breastfeeding rate among mothers taking buprenorphine for opiate dependency may be lower than in other mothers, especially with multiple buprenorphine initiation attempts; however, among women taking buprenorphine as part of an abstinence program, the retention rate may be better in nursing mothers than in non-breastfeeding mothers.

“Summary of Use during Lactation”, LactMed record “Buprenorphine” (LM338), quoted verbatim. Everything LactMed reports about Buprenorphine while breastfeeding.

8.2 Lactation Risk Summary Based on two studies in 13 lactating women maintained on buprenorphine treatment, buprenorphine and its metabolite norbuprenorphine were present in low levels in human milk, and available data have not shown adverse reactions in breastfed infants. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Buprenorphine Sublingual Tablets and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Prescribing label, section “8.2 Lactation” (opening excerpt): buprenorphine hydrochloride (sublingual), Advagen Pharma Ltd. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

This quote is from the sublingual formulation label.