Can I take fentanyl while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with Fentanyl Citrate Injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes. There are adverse outcomes reported with fetal exposure to opioid analgesics (see Clinical Considerations) . In animal reproduction\ studies, fentanyl administration to pregnant rats during organogenesis was embryocidal at doses within the range of the human recommended dosing. No evidence of malformations was noted in animal studies completed to date [see Data] . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Fentanyl Citrate (intramuscular, intravenous), Hikma Pharmaceuticals USA Inc. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

This quote is from the intramuscular/intravenous formulation label.

When used epidurally or intravenously during labor or for a short time immediately postpartum, amounts of fentanyl ingested by the neonate are usually small and are not expected to cause any adverse effects in breastfed infants. Preterm infants are the most susceptible to fentanyl’s effects because their clearance is substantially reduced.[1] The results of studies on the effect of epidural fentanyl on breastfeeding initiation and duration are mixed, because of the many different combinations of drugs, dosages and patient populations studied as well as the variety of techniques used and deficient designs of many of the studies. It has been suggested that a cumulative dose of 80 to 150 mcg of fentanyl during labor and delivery reduces breastfeeding success,[2-4] but another study found no marked decrease in breastfeeding success with doses above 150 mcg in motivated women with previous breastfeeding success.[5] In infants placed skin-to-skin after a normal vaginal delivery, epidural fentanyl given during labor may delay the infant’s first suckling in a dose-dependent manner,[6] perhaps because it can persist in the infant’s serum for over 24 hours after discontinuation.[7] However, it appears that with good breastfeeding support, epidural fentanyl plus bupivacaine has little overall effect on breastfeeding success.[8-12]

No waiting period or discarding of milk is required before resuming breastfeeding after fentanyl is used for short procedures (e.g., for endoscopy).[13,14] After general anesthesia, breastfeeding can be resumed as soon as the mother has recovered sufficiently from anesthesia to nurse. When a combination of anesthetic agents is used for a procedure, follow the recommendations for the most problematic medication used during the procedure. Limited information indicates that transdermal fentanyl in a dosage of 100 mcg/hour results in undetectable fentanyl concentrations in breastmilk.

Mothers with opioid use disorder who are using fentanyl have lower breastfeeding initiation rates than other mothers with opioid use disorder.[15] Breastfeeding 72 hours after the birthing parent’s last use of nonprescribed fentanyl has been used along with treatment for substance use disorder, newborn care and observation, and ongoing social and medical support.[16]

“Summary of Use during Lactation”, LactMed record “Fentanyl” (LM356), quoted verbatim. Everything LactMed reports about Fentanyl while breastfeeding.

8.2 Lactation Risk Summary Fentanyl is present in breast milk. One published lactation study reports a relative infant dose of fentanyl of 0.38%. However, there is insufficient information to determine the effects of fentanyl on the breastfed infant and the effects of fentanyl on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Fentanyl Citrate Injection and any potential adverse effects on the breastfed infant from Fentanyl Citrate Injection or from the underlying maternal condition.

Prescribing label, section “8.2 Lactation” (opening excerpt): Fentanyl Citrate (intramuscular, intravenous), Hikma Pharmaceuticals USA Inc. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

This quote is from the intramuscular/intravenous formulation label.