Is Xtampza ER Safe in Breastfeeding

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

• DrLact safety Score for Xtampza ER is 5 out of 8 which is considered Unsafe as per our analyses.
• A safety Score of 5 indicates that usage of Xtampza ER may cause serious side effects in breastfed baby.
• Our study of different scientific research indicates that Xtampza ER may cause moderate to high side effects or may affect milk supply in lactating mother.
• Our suggestion is to use safer alternate options rather than using Xtampza ER .
• It is recommended to evaluate the advantage of not breastfeeding while using Xtampza ER Vs not using Xtampza ER And continue breastfeeding.
• While using Xtampza ER Its must to monitor child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to dosage.
• Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Very often used for treatment of pain associated to episiotomy or Cesarean section operation. Excreted and accumulates into breast milk in significant amount along with associated problems among 20% of breastfed infants from treated mothers. Side effects have been rarely severe like excessive sedation, letargia, hypothermia and apnea. Dose should not be higher than 30 mg a day for no longer than 3 days. Women with some variants of enzyme-linked gene CYP2D6 who are on Xtampza ER and their breastfed infants may experience increased sedation. Dose should not be higher than 30 mg a day for no longer than 3 days. Use of Xtampza ER during childhood is risky because of a large elimination half-life variability. Adequately use of nonsteroidal anti-inflammatory drugs (NSAIDs) may attain pain relief with less side effects than with narcotic analgesics.

Maternal use of oral narcotics during breastfeeding can cause infant drowsiness, central nervous system depression and even death. Infant sedation is common and well documented with maternal use of Xtampza ER. 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 oral Xtampza ER (and combinations) to a 2 to 3 days, especially in the outpatient setting.[1] A maximum Xtampza ER dosage of 30 mg daily is suggested, although some sources recommend avoiding Xtampza ER during breastfeeding.[2][3] Xtampza ER elimination is decreased in young infants with much inter-individual variability. Monitor the infant closely for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants. If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately. Other agents are preferred over Xtampza ER during breastfeeding.[2]

A 10-month-old, 7.7 kg infant of a prescription drug-dependant mother died of cardiac arrest after a 12- to 24-hour period of lethargy, hypersomnolence and dyspnea. The infant also had a recent history of fever. The mother had reportedly been breastfeeding the infant 3 times a day for several weeks and had taken 180 mg of Xtampza ER, as well as muscle relaxants, the day prior to her infant's death. A blood Xtampza ER level of 600 mcg/L was measured on autopsy. The medical examiner considered it unlikely that such a high level of Xtampza ER in the infant's blood could be due to breastfeeding exposure as reported by the mother and thus considered the death a homicide resulting from either the intentional administration of Xtampza ER directly to the infant or from a higher dose of Xtampza ER in breastmilk than that reported by the mother.[9] In a study of 50 mothers taking Xtampza ER post-cesarean section, 50 neonates were evaluated for sedation over 48 hours after birth. None was severely sedated and less than 4% had sedation of 3 on a 1 (fully alert) to 5 (difficult to rouse) scale and none more sedated than 3 on the scale. Because these infants were in the first 3 days postpartum, their Xtampza ER dose was probably limited by the small volumes of colostrum they were ingesting.[7] An infant was born to a mother taking Xtampza ER 20 mg 3 times daily, fluoxetine 40 mg daily and quetiapine 400 mg daily. The infant was breastfed 6 to 7 times daily and was receiving 120 mcg of oral morphine 3 times daily for opiate withdrawal. Upon examination at 3 months of age, the infant's weight was at the 25th percentile for age, having been at the 50th percentile at birth. The authors attributed the weight loss to opiate withdrawal. The infant's Denver developmental score was equal to his chronological age.[10] A woman who was exclusively breastfeeding her infant was taking 5 to 10 mg of Xtampza ER every 4 to 6 hours for episiotomy pain. Her 45-day-old infant was brought to the emergency department with a temperature of 98.4 degrees F, a heart rate of 154 per minute, 20 breaths per minute, a blood pressure of 71/52, and an oxygen saturation of 60% to 69% on room air. The infant had been constipated since birth, passing one stool every 5 to 8 days. The infant had sluggish movements slow, shallow, and irregular breathing. Her pupils were small, but reactive. Hydromorphone levels in urine were elevated. The patient was intubated and given opiates around the clock for two days before being extubated and discharged. The infant's constipation, CNS and respiratory depression were probably caused by Xtampza ER in breastmilk.[8] In a retrospective study, nursing mothers who were taking either Xtampza ER, codeine or acetaminophen for pain while breastfeeding were contacted by telephone to ascertain the degree of maternally perceived central nervous system (CNS) depression. Mothers taking Xtampza ER reported signs of CNS depression in 20% (28/139) of their infants, while those taking acetaminophen reported infant CNS depression in only 0.5% (1/184) of their infants. Women who reported infant sedation were taking 0.4 mg/kg daily of Xtampza ER, and unaffected were taking 0.15 mg/kg daily. Affected infants had more hours of daily uninterrupted sleep than unaffected infants, and 4 of the affected infants reportedly had "irregular breathing". Thirty-eight of 39 mothers reported that infant sedation ceased with maternal Xtampza ER discontinuation. Mothers of affected infants were also more likely to experience lethargy and other side effects than mothers of unaffected infants. Mothers who took codeine reported a similar rate of infant sedation (17%) compared to Xtampza ER, but the groups were statistically different in parity and postmenstrual age (PMA), with the codeine group having a slightly higher PMA.[11] A newborn infant was exclusively breastfed and found to be well by his physician at 2 days of age. At 3 days postpartum, the infant began to be sedated and became difficult to arouse and did not feed from either breast. At 4 days of age, the infant was brought to the emergency department where the infant was found to have lethargy, hypothermia, pinpoint pupils, and a poor sucking reflex. The mother reported that her milk had come in the previous evening. She had taken 10 mg of Xtampza ER that evening and another 5 mg the next morning in the form of Percocet (Xtampza ER 5 mg plus acetaminophen 325 mg). The infant was given naloxone 0.34 mg intramuscularly and within 2 minutes, the baby's eyes opened and he drank 45 mL of formula. No further sedation was seen over the next 24 hours.[12] The infant's sedation was probably caused by Xtampza ER in breastmilk.

Xtampza ER can increase serum prolactin.[13] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.