Is Buprenorphine safe while breastfeeding?

Effects on the breastfed infant

Numerous infants have been reported to breastfeed during maternal narcotic abstinence therapy with buprenorphine with no adverse effects, one for 6 months.[ 15 , 18 , 27 - 29 ] The amounts of buprenorphine in milk may not be sufficient to prevent neonatal withdrawal, and treatment of infant may be required.[ 17 , 30 ] Despite breastfeeding and relatively high infant serum drug levels, mild buprenorphine withdrawal occurred in the neonate of a mother taking buprenorphine 4 mg daily (route not specified) during pregnancy and postpartum for heroin dependency.[ 15 ] This indicates that an insufficient dosage appeared in milk to prevent neonatal abstinence. Ten women who had undergone cesarean section delivery of term newborns were given extradural buprenorphine 200 mcg followed by 8.4 mcg/hour with an anesthetic for postoperative pain for 3 days postpartum. A control group of 10 other women were given extradural anesthetic only without buprenorphine. Over 11 days postpartum, newborns of mothers in the buprenorphine group had much lower milk intake and lower weight gain than those in the non-buprenorphine group. The authors suggested that extradural buprenorphine suppressed infant breastfeeding. Infant neurobehavioral assessments were not performed.[ 31 ] Six infants whose mothers were taking buprenorphine during pregnancy and postpartum were breastfed. Four of the infants had signs of opioid abstinence, indicating that the amounts of buprenorphine in breastmilk were inadequate to prevent withdrawal. At 1 month after discharge from the hospital, all infants had normal development and weight gain.[ 20 ] Seven infants who averaged 1.12 months of age (range 0.58 to 1.85 months) were breastfed by mothers taking buprenorphine for opiate substitution during pregnancy and lactation. Urine screening indicated that 4 mothers had also been using cannabis, 1 was using unprescribed benzodiazepines, and 1 mother was using both cannabis and benzodiazepines. Four of the infants were ex

Effects on milk supply

Buprenorphine can increase serum prolactin.[ 40 ] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed. In a multicenter prospective study of 246 pregnant women receiving either methadone or buprenorphine for opiate dependency, 153 women were receiving high-dose buprenorphine. Twenty-two percent of women receiving buprenorphine breastfed their infants, which was the same percentage as those receiving methadone.[ 41 ] A retrospective chart review of 276 opiate-dependent mothers who delivered in a Baby Friendly Hospital found that mothers taking buprenorphine or methadone for opiate dependency were unlikely to breastfeed their infants. Only 45% of the 20 mothers on buprenorphine maintenance initiated breastfeeding. Of all women in the study, 60% discontinued breastfeeding before discharge from the hospital.[ 42 ] A retrospective case series reported on 85 opioid-dependent women maintained on buprenorphine during pregnancy and postpartum during the period of December 2007 to August 2012. Of these women, 65 were breastfeeding on discharge from the hospital and 66% of these were breastfeeding at their 6- to 8-week follow-up appointment (extent of nursing not stated).[ 43 ] A retrospective cohort study in Australia compared breastfeeding rates on discharge of drug-using mothers who were taking either buprenorphine, other opiates or nonopioids (e.g., benzodiazepines, amphetamines, cocaine, alcohol, inhalants, cannabinoids, psychotropics). Breastfeeding rates at discharge from the hospital were as follows: buprenorphine 27%, other opiates 31%, and nonopioids 51%.[ 44 ] A small retrospective study found that only 3 of 10 pregnant women treated with buprenorphine plus naloxone for opioid dependence were breastfeeding their infants at the time of hospital discharge.[ 45 ] A retrospective cohort study of 150 women enrolled in a substance abuse treatment program found that women taking methadone had a higher prevalence of b

Levels in milk

Buprenorphine has poor oral bioavailability and is usually given by the sublingual or parenteral route. Sublingual bioavailability is 30 to 40% in adults and peak levels in blood occur 60 to 90 minutes after a dose. Buprenorphine is metabolized to the slightly active metabolite, norbuprenorphine. Further metabolism is by glucuronidation to active metabolites. Maternal Levels. A breastfeeding mother taking sublingual buprenorphine maintenance 4 mg daily during pregnancy and lactation had milk samples collected 6 times over the course of a day at 4 weeks postpartum. Milk levels and milk volumes ingested by the infant were measured, but not reported. The authors estimated that the total dose ingested by the infant over 1 day was 3.28 mcg of buprenorphine and 0.33 mcg of norbuprenorphine.[ 15 ] Assuming an infant weight of 4 kg, the infant dosage in this study is equivalent to about 1.4% of the maternal weight-adjusted dosage. Four mothers who were 4 days postpartum and were taking 0.4, 2, 4 or 6 mg of oral buprenorphine maintenance once daily during pregnancy and lactation had their milk collected 2, 4, 6 and 12 hours after a dose. Peak milk levels occurred 2 hours after the dose in the mothers taking 2 and 4 mg and 4 hours after the dose in the mother taking 6 mg daily. Peak levels were 0.8, 7.8 and 5.8 mcg/L, respectively. Milk levels of buprenorphine and norbuprenorphine were undetectable (lower limit of the assay not given) in the mother taking buprenorphine 0.4 mg daily. Average milk levels in the mothers taking 2, 4 and 6 mg were 0.4, 3.5, and 4.4 mcg/L of buprenorphine and 0.57, 0.45, and 1.15 mcg/L of norbuprenorphine, respectively.[ 16 , 17 ] Based on the average milk levels reported, an exclusively breastfed infant would receive less than 1% of the maternal weight-adjusted dosage. Dosages were on the low end of the usual dosage range for treatment of opiate withdrawal. Furthermore, the authors reported that the mothers' doses were given orally. The oral route

Alternatives LactMed lists

• Butorphanol
• Fentanyl
• Hydromorphone
• Ibuprofen
• Naltrexone