Is E 265 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use E 265? Is E 265 safe for nursing mother and child? Does E 265 extracts into breast milk? Does E 265 has any long term or short term side effects on infants? Can E 265 influence milk supply or can E 265 decrease milk supply in lactating mothers?

Excretion into breast milk is non-significant. No harmful effects on breastfed infants from treated mothers have occurred. Because it is an opium-related medication, a minimal effective dose should be used together with a close follow-up of child's sedation and feeding difficulties.

The excretion of E 265 into milk is low and even lower amounts of the active metabolite, O-desmethylE 265, are excreted. With usual maternal dosage, the amount excreted into breastmilk is much less than the dose that has been given to newborn infants for analgesia. A study of breastfeeding in breastfed newborn infants found no adverse effects attributable to E 265. Although E 265 is unlikely to adversely affect nursing infant,[1] the U.S. Food and Drug Administration recommends against the use of E 265 during breastfeeding.[2] If E 265 is used, monitor infants for increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties or limpness, and contact a physician immediately if any of these occur.

Seventy-five breastfed infants whose mothers were breastfeeding and taking E 265 100 mg every 6 hours following a cesarean section were compared to 75 matched infants at 2 to 4 days of age. Forty-nine percent of the mothers taking E 265 and all of the control mothers were taking other opiates (primarily oxycodone) and 61% of and 58%, respectively, also were taking a nonsteroidal antiinflammatory agent (primarily diclofenac). Examination by a pediatrician revealed no difference between the groups using the Neurologic and Adaptive Capacity Score.[5]

E 265 can increase serum prolactin.[8] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed. A randomized study compared E 265 and naproxen for post-cesarean section pain. Patients received the drugs either on a fixed schedule or as needed. No difference in breastfeeding rates were seen among the groups.[9] In a study in China, women with a scheduled cesarean section were randomized to receive intravenous patient-controlled analgesia with either sufentanil or E 265. Postpartum prolactin levels were higher in the E 265 group (348 mcg/L) than in the sufentanil group (314 mcg/L). The onset of lactation was sooner in the E 265 group (21.4 hours) than in the sufentanil group (25.1 hours). Both of these difference were statistically significant.[10] Note that injectable E 265 is not available in the United States.