Is Buprenorphine Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Buprenorphine? Is Buprenorphine safe for nursing mother and child? Does Buprenorphine extracts into breast milk? Does Buprenorphine has any long term or short term side effects on infants? Can Buprenorphine influence milk supply or can Buprenorphine decrease milk supply in lactating mothers?

It is a semi-synthetic opioid which is used to replace Methadone in the treatment of opioid addiction. Mothers on Buprenorphine showed a shorter mean hospital stay than those who were treated with Methadone. The amount of dose reaching the infant is minimal and has no untoward side effects. It has been noticed a mild and transient abstinence syndrome after birth when sudden withdrawn occurred. Addiction to narcotic drugs and the use of substitutive treatments lowers the breastfeeding rate and duration of nursing.

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. 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. Observe infants for withdrawal signs if breastfeeding is stopped abruptly. 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][2][3][4][5][6][7][8][9][10] The long-term outcome of infants breastfed during maternal buprenorphine therapy for opiate abuse has not been well studied.[11] The breastfeeding rate among mothers taking buprenorphine for opiate dependency may be lower than in other mothers.

Numerous infants have been reported to breastfeed during maternal narcotic abstinence therapy with buprenorphine with no adverse effects,[12][15][21][22][23] one for 6 months.[21] The amounts of buprenorphine in milk may not be sufficient to prevent neonatal withdrawal, and treatment of infant may be required.[14][24] 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.[12] 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 anaesthetic 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.[25] 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.[17] Seven infant who averaged 1.12 months of age (range 0.58 to 1.85 months) were being 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 exclusively breastfed and 3 were mostly breastfed. Infants had no apparent drug-related adverse effects and showed satisfactory developmental progress.[18] A mother used buprenorphine (dose and indication not stated) during pregnancy. Her infant displayed no signs of neonatal abstinence at birth. The infant was breastfed (extent not stated) until 4 months of age when the mother stopped breastfeeding. Two days later the infant had withdrawal symptoms including frequent yawning, sneezing, pupillary dilation, agitation, sweating, hyperactive Moro reflex, myoclonic jerks, tremors, and insomnia. The infant was given methadone with immediate improvement of her withdrawal symptoms. The infant's withdrawal symptoms were probably caused by abrupt withdrawal of breastfeeding.[26] In a study of 7 women taking buprenorphine in a median dose of 7 mg daily (range 2.4 to 24 mg daily) , breastfed infants were followed-up at 3 and 4 weeks of age. Four infants were exclusively breastfed and 3 were partially breastfed. At the follow-up visits, infants were assessed for weight gain, sleeping patterns, skin color, and elimination and hydration patterns. All infants had values within normal limits for these parameters at follow-up.[27] A cohort of 124 infants exposed during pregnancy to maternal medication for opioid maintenance therapy were followed postpartum in a Norwegian study. Forty-six infants were born to mothers taking buprenorphine. Overall, infants who were breastfed had a lower rate of neonatal abstinence symptoms and a shorter duration of therapy for neonatal abstinence. However, the differences were not statistically significant for the subset of infants whose mothers took buprenorphine.[28] A study of pregnant women being treated for opiate dependency with buprenorphine at a clinic in Vienna were followed as were their newborn infants. No difference was found between breastfed (n = 31) and nonbreastfed infant (n = 41) in average measures of neonatal abstinence, dosage requirements of morphine, durations of treatment for neonatal abstinence or durations of hospital stays.[29] A study of 89 pregnant women were treated with buprenorphine for maintenance of opioid abstinence. Fewer of their infants who were exclusively breastfed required morphine for neonatal abstinence symptoms than those who were not exclusively breastfed. Exclusively breastfed infants had an earlier time to peak abstinence symptoms and fewer days in the hospital than the nonexclusively breastfed infants.[30]

Buprenorphine can increase serum prolactin.[31] 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.[32] 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.[33] 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).[34] A retrospective cohort study in Australia compared breastfeeding rates on discharge of drug-using mothers who were taking either buprenorphine, other opiates or nonopiates (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 nonopiates 51%.[35] 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.[36] A retrospective cohort study of 150 women enrolled in a substance abuse treatment program found that women taking methadone had a higher prevalence of breastfeeding than women taking buprenorphine plus naloxone. However, this difference appeard to be related to the greater intention to breastfeed before delivery in the methadone group.[37] A retrospective cohort study of 228 women enrolled in a perinatal substance abuse treatment program found that women taking buprenorphine had a higher prevalence of breastfeeding than women taking methadone. The intention to breastfeed before delivery was similar in both groups.[38]