Is Subsys Safe in Breastfeeding

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

Opium-derived analgesic that is used through several ways of administration (epidural, intravenous, mouth, skin). It is excreted into breast milk in non-significant amount without observed problems among infants from treated mothers. Plasma levels of those infants were undetectable. It has been authorized for treatment of small infants and neonates. After a mother has underwent anesthesia by the use of Subsys, she may breastfeed her baby as soon as her recovery and general conditions may permit it. Subsys stimulates secretion of Prolactin, however, after Lactation has been established, Prolactin level has a poor relationship with production of mother's milk. There is controversy about the effect of analgesic medication used for labor management (Epidural anesthesia with Subsys added or not ) on the initiation of breastfeeding, both on starting of phase II of Lactogenesis or the infant ability for suckling. Some studies have pointed out to a higher risk for a delay in the initiation of Lactogenesis II (milk coming in) for longer than 3 days after birth, even though it would not affect the weight loss of the newborn. Other studies have found a higher risk for a delay in the first latch-on at the breast, higher body temperature and irritability or somnolence. Some others however, failed to show the same findings. It appears to be of more paramount importance the women's support for the establishment and continuation of breastfeeding, than the negative effect that would be exerted by administration of analgesia or anesthesia during labor. Fentany has lesser effect than Pethidine (Demerol) on initiation of breastfeeding. It occurs a higher milk production and weight increase of the infant if there is an adequate pharmacological control of the pain that appears after vaginal birth or C-section. The American Academy of Pediatrics - says that is usually compatible with breastfeeding.

When used epidurally or intravenously during labor or for a short time immediately postpartum, amounts of Subsys ingested by the neonate are usually small and are not expected to cause any adverse effects in breastfed infants. The results of studies on the effect of epidural Subsys on breastfeeding initiation and duration are mixed and controversial, 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. In infants placed skin-to-skin after a normal vaginal delivery, epidural Subsys given during labor may delay the infant's first suckling in a dose-dependent manner,[1] perhaps because it can persist in the infant's serum for over 24 hours after discontinuation.[2] However, it appears that with good breastfeeding support, epidural Subsys plus bupivacaine has little overall effect on breastfeeding success.[3][4][5][6][7] No waiting period or discarding of milk is required before resuming breastfeeding after Subsys is used for short procedures (e.g., for endoscopy).[8][9] 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 Subsys in a dosage of 100 mcg/hour results in undetectable Subsys concentrations in breastmilk. Newborn infants seem to be particularly sensitive to the effects of even small dosages of narcotic analgesics. Once the mother's milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of Subsys to a few days at a low dosage with close infant monitoring. If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately.

Subsys was possibly the cause of statistically significant, but clinically unimportant, lower neurobehavioral scores in a group of 32 newborns who were less than 24 hours old and whose mothers had received epidural Subsys during labor.[16] An epidural Subsys dosage greater than 150 mcg during labor was associated with slightly lower neurobehavioral scores in the newborns of 177 breastfeeding mothers on postpartum day 1 compared to a lower total dosage or to no Subsys;[17] however, this might have been a chance association[18] and was probably due to placental transfer of Subsys prior to delivery and not from breastmilk after delivery. All women also received epidural bupivacaine. A woman was using a transdermal Subsys patch for chronic back pain during pregnancy and postpartum. The mother required additional analgesia during labor and the infant required treatment for neonatal abstinence syndrome. By 2 weeks postpartum, the mother was using a Subsys patch in a dosage of 100 mcg/hour which was changed every other day and the infant was being fed the mother's milk every 3 hours. The infant had no additional medical problems and fed well until discharge after day 27 of life, gaining 500 g.[15]

Subsys can increase serum prolactin.[19][20] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed. In 58 breastfeeding mothers who received an epidural Subsys dosage greater than 150 mcg during labor, 21% reported more difficulty in establishing breastfeeding at 24 hours after delivery compared to 10% of mothers who received to a lower dosage or to no Subsys. There was no difference in breastfeeding difficulty noted between the groups 24 hours after delivery when the assessment was performed by a lactation consultant. Women in the high-dose group who could be contacted were more likely to discontinue breastfeeding by 6 weeks after delivery and there was a higher rate of breastfeeding discontinuation at 6 weeks among mothers who reported breastfeeding difficulty 24 hours after delivery.[17] A relatively high dropout rate from the study at 6 weeks clouds the results.[18] A retrospective study of a random sample of 425 mothers delivering in a maternity unit found a dose-related increased risk of bottle feeding at hospital discharge associated with Subsys administered during labor.[21] A prospective cohort study compared women who received continuous epidural analgesia with Subsys and either bupivacaine or ropivacaine during labor and delivery (n = 52) to women who received no analgesia (n = 63). The average total Subsys dosage was 124 mcg and the average total infusion time from start to delivery was 219 minutes. The study found no differences between the groups in breastfeeding effectiveness or infant neurobehavioral status at 8 to 12 hours postpartum or the number exclusively or partially breastfeeding at 4 weeks postpartum.[22] A randomized, prospective study measured infant breastfeeding behavior following epidural or intravenous Subsys during delivery in 100 multiparous mothers undergoing cesarean section and delivering fullterm, healthy infants. Epidural Subsys was given to 50 women in a dose of 100 to 150 mcg in divided doses followed by a continuous epidural infusion of 20 mcg/hour. Intravenous Subsys was given to 50 women as a single dose of 50 mcg after delivery. Both groups received epidural or spinal bupivacaine in addition. A slight difference was seen in breastfeeding behavior between the groups, with the infants in the intravenous Subsys group performing slightly worse than those in the epidural group. However, all mothers were able to breastfeed their infants at 24 hours. None had severe breastfeeding problems; 10 women in the epidural group reported mild or moderate problems and 7 women in the intravenous group reported breastfeeding problems. Twenty mothers in the epidural group and 14 in the intravenous group used supplemental bottle feeding, with the difference not statistically significant.[14] A randomized, multicenter trial compared the initiation rate and duration of breastfeeding in women who received high-dose epidural bupivacaine alone, or one of two low-dose combinations of bupivacaine plus Subsys. The average Subsys dosages in the two groups were 97 and 151 mcg in the first stage of labor and 10 and 12 mcg of Subsys during the second stage of labor, respectively, with great variability. A nonepidural matched control group was also compared. No differences in breastfeeding initiation rates or duration were found among the epidural and nonmedicated groups, but women in the nonepidural group who received systemic meperidine had a lower breastfeeding initiation rate than in the other groups.[23] A nonrandomized study in low-risk mother-infant pairs found that there was no difference overall in the amount of sucking by newborns, whether their mothers received bupivacaine plus Subsys, or Subsys alone by epidural infusion in various dosages, or received no analgesia for childbirth. In a subanalysis by sex and number of sucks, female infants were affected by high-dose bupivacaine and high-dose Subsys, but male infant were not.[24] However, the imbalances of many factors between the study groups makes this study difficult to interpret. In a prospective cohort study, 87 multiparous women who received epidural bupivacaine and Subsys for pain control during labor and vaginal delivery. A loading dose of 0.125% bupivacaine with Subsys 50-100 mcg. Epidural analgesia is maintained using 0.0625% bupivacaine and Subsys 0.2 mcg/mL. The median dose of Subsys received by the women was 151 mcg (range 30 to 570 mcg). The women completed questionnaires at 1 and 6 weeks postpartum regarding breastfeeding. Most women had prior experience with breastfeeding, support at home and ample time off from work. All women were breastfeeding at 1 week postpartum and 95.4% of women were breastfeeding at 6 weeks postpartum.[25] A nonrandomized study at one Italian hospital compared primaparous mothers undergoing vaginal delivery who received epidural analgesia (n = 64) to those who did not (n = 64). Mothers who reques