Is Sublocade Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Sublocade? Is Sublocade safe for nursing mother and child? Does Sublocade extracts into breast milk? Does Sublocade has any long term or short term side effects on infants? Can Sublocade influence milk supply or can Sublocade 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 Sublocade 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 It has been noticed a mild and transient abstinence syndrome after birth when sudden withdrawn occurred.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 Sublocade 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 Sublocade 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 Sublocade therapy for opiate abuse has not been well studied.[11] The breastfeeding rate among mothers taking Sublocade for opiate dependency may be lower than in other mothers.

Numerous infants have been reported to breastfeed during maternal narcotic abstinence therapy with Sublocade with no adverse effects,[12][15][21][22][23] one for 6 months.[21] The amounts of Sublocade 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 Sublocade withdrawal occurred in the neonate of a mother taking Sublocade 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 Sublocade 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 Sublocade. Over 11 days postpartum, newborns of mothers in the Sublocade group had much lower milk intake and lower weight gain than those in the non-Sublocade group. The authors suggested that extradural Sublocade suppressed infant breastfeeding. Infant neurobehavioral assessments were not performed.[25] Six infants whose mothers were taking Sublocade during pregnancy and postpartum were breastfed. Four of the infants had signs of opioid abstinence, indicating that the amounts of Sublocade 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 Sublocade 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 Sublocade (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 Sublocade 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 Sublocade. 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 Sublocade.[28] A study of pregnant women being treated for opiate dependency with Sublocade 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 Sublocade 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]

Sublocade 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 Sublocade for opiate dependency, 153 women were receiving high-dose Sublocade. Twenty-two percent of women receiving Sublocade 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 Sublocade or methadone for opiate dependency were unlikely to breastfeed their infants. Only 45% of the 20 mothers on Sublocade 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 Sublocade 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 Sublocade, other opiates or nonopiates (e.g., benzodiazepines, amphetamines, cocaine, alcohol, inhalants, cannabinoids, psychotropics). Breastfeeding rates at discharge from the hospital were as follows: Sublocade 27%, other opiates 31%, and nonopiates 51%.[35] A small retrospective study found that only 3 of 10 pregnant women treated with Sublocade 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 Sublocade 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 Sublocade had a higher prevalence of breastfeeding than women taking methadone. The intention to breastfeed before delivery was similar in both groups.[38]