Is Ketalgin Safe in Breastfeeding

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

Drugs used in the treatment of opioid dependence and treatment of neonatal opiate withdrawal. It is excreted in breast milk in clinically non-significant amount without problems in the short or long term in infants whose mothers were treated. Plasma levels of these infants were undetectable or very low. The dose that gets the infant through the mother's milk, even when taking 70-150 mg a-day, is much lower than that used to treat neonatal abstinence syndrome. This is a reason for not using it as a solely measure of treatment. It should be reinforced that it is observed a non-polydrug behavior and adequacy of maternal care is maintained. Many newborns are either premature or underweight infants, and over 60% develop withdrawal syndrome at about one post-natal month. Breastfeeding with regard to the entire context of addictive behavior is neither easy nor frequently achieved. Much help is needed on supporting addicted mothers by health and social services in the community. Ketalgin excretion into breast milk is minimal regardless of the dose taken by the mother. No correlation was found between maternal dose and concentration in either breast milk or infant plasma.It has been shown delayed onset of neonatal abstinence syndrome, less need for drug treatment and lower average of hospital stay in breastfed infants.High doses can lead to a slow start (within 2-6 weeks) of withdrawal syndrome when breastfeeding is suddenly stopped. Ketalgin can cause galactorrhea due to increased prolactin secretion.

Most infants receive an estimated dose of Ketalgin ranging from 1 to 3% of the mother's weight-adjusted Ketalgin dosage with a few receiving 5 to 6%, which is less than the dosage used for treating neonatal abstinence. Initiation of Ketalgin postpartum, or increasing the maternal dosage to greater than 100 mg daily therapeutically or by abuse while breastfeeding poses a risk of sedation and respiratory depression in the breastfed infant, especially if the infant was not exposed to Ketalgin in utero. If the baby shows signs of increased sleepiness (more than usual), breathing difficulties, or limpness, a physician should be contacted immediately. Other agents are preferred over Ketalgin for pain control during breastfeeding. Women who received Ketalgin maintenance 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] Breastfeeding may decrease, but not eliminate, neonatal withdrawal symptoms in infants who were exposed in utero. Some studies have found shorter hospital stays, durations of neonatal abstinence therapy and shorter durations of therapy among breastfed infants, although the dosage of opiates used for neonatal abstinence may not be reduced.[8][9][11][12][13][14][15][16][17] The long-term outcome of infants breastfed during maternal Ketalgin therapy for opiate abuse has not been well studied.[18] Abrupt weaning of breastfed infants of women on Ketalgin maintenance might result in precipitation of or an increase in infant withdrawal symptoms, and gradual weaning is advised. The breastfeeding rate among mothers taking Ketalgin for opiate dependency has been lower than in mothers not using Ketalgin in some studies, but this finding appears to vary by institution, indicating that other factors may be important.

One center reported 10 women who breastfed during Ketalgin maintenance with no observed adverse effects in their infants.[22] The death of a 5-week-old infant who was born 1 week prematurely to a former heroin-abusing mother was possibly related to Ketalgin in breastmilk. The infant had been breastfeeding since birth and the mother was taking an unreported daily dose of oral Ketalgin maintenance. The medical examiner's diagnosis was Ketalgin intoxication. A high level of Ketalgin was found in the infant's serum at autopsy; however, the high level might have been caused by postpartum redistribution (which can be 2- to 10-fold[36]). The infant was also noted to be "obviously malnourished." Abnormal brain, liver and other organs on autopsy were also found and it appeared that the infant had been neglected.[37][38] Three breastfed term infants of mothers taking oral Ketalgin maintenance 45 to 70 mg daily during pregnancy and lactation had no reported adverse effects. They were cared for in a well-baby nursery after birth and discharged in good health home with their mothers at 2 to 3 days of age. At follow up over 3 weeks to 6 months of age, the infants had no symptoms of sedation or Ketalgin withdrawal while breastfeeding. One infant who had breastfeeding discontinued at 3 weeks of age developed withdrawal symptoms of hyperirritability and sleeplessness. The other 2 infants were slowly weaned over 4 to 6 months and did not experience withdrawal upon breastfeeding discontinuation. The authors cautioned against abrupt breastfeeding discontinuation during Ketalgin maintenance.[25] A partially breastfed 3.5-month-old infant of a mother taking oral Ketalgin maintenance 73 mg once daily died of sudden infant death syndrome. The mother was reportedly mostly bottle feeding the infant due to diminished milk supply. There was no Ketalgin detected in the infant's blood at autopsy (lower limit of the assay not reported).[24] Twelve term breastfed (extent not stated) newborns of mothers taking oral Ketalgin maintenance (range 20 to 80 mg daily) during pregnancy and lactation were observed during their first week of age. Seven of these infants developed Ketalgin withdrawal and 6 required treatment. The authors considered maternal Ketalgin maintenance to be compatible with breastfeeding in the first week of a newborn's life but cautioned that newborn Ketalgin withdrawal may occur despite breastfeeding.[27] The hospital course of 88 breastfed newborns were compared to 32 non-breastfed newborns. All had mothers taking oral Ketalgin maintenance at an average dose of 40 mg daily (range 5 to 175 mg daily). Although the breastfed newborns developed neonatal abstinence syndrome and required rehospitalization after discharge at the same rate as bottle-fed infants, they did have a shorter hospital stay than bottle-fed newborns.[39] Two fully breastfed term infants of mothers taking oral Ketalgin maintenance 70 and 130 mg daily during pregnancy and lactation had no adverse effects and required no treatment for Ketalgin withdrawal prior to postpartum hospital discharge at 8 and 6 days of age, respectively. Both infants were rehospitalized and treated for Ketalgin withdrawal symptoms at 6 weeks and 17 days of age, respectively, shortly after their mothers abruptly discontinued breastfeeding. The authors surmised that the appearance of symptoms were probably due to withdrawal from Ketalgin in breastmilk.[40] A Swiss descriptive report found that among the newborns of 84 mothers on Ketalgin maintenance, the neonatal abstinence syndrome was less frequent in breastfed infants than in non-breastfed infants, 26% and 78%, respectively. Twenty-seven infants were breastfed and 54 were formula-fed. "Breastfed" was defined by the authors as more than 50% of feeding from breastmilk while in the hospital.[41] A 5-week-old breastfed infant became cyanotic and required mouth-to-mouth resuscitation and intubation. The infant's urine was positive for opioids and the infant responded positively to naloxone; the level of consciousness improved over 2 days and extubation was accomplished. The infant's mother admitted to taking Ketalgin and a hydrocodone-acetaminophen combination product that had been prescribed for migraine headache before she was breastfeeding.[42] A retrospective review from Australia was conducted on the medical records of 190 drug-dependent mothers and their infants. One hundred forty-nine of the mothers were taking Ketalgin at delivery; 62 mothers taking Ketalgin (average dose 68.5 mg daily; maximum dose 150 mg daily) breastfed their infants and 87 mothers taking Ketalgin (average dose 79.6 mg daily) formula-fed their infants. Breastfed infants had a longer median time to withdrawal symptoms (10 days) than formula-fed infants (3 days). Breastfed infants were less likely to require pharmacologic treatment and doses of morphine required to treat withdrawal were lower in breastfed infants. Treatment durat

Ketalgin can increase serum prolactin.[53] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed. In a French multicenter prospective study of 246 pregnant women in receiving either Ketalgin or buprenorphine for opiate dependency, 93 women were receiving Ketalgin. Twenty-four percent of women receiving Ketalgin breastfed their infants, which was not different from those receiving buprenorphine.[54] Successful breastfeeding was reported in New Zealand in 15 infants whose mothers were taking Ketalgin for pain and 18 infants whose mothers were taking Ketalgin for maintenance of narcotic abstinence. Both groups of mothers were taking a wide range of doses with median daily dosages of 40 and 60 mg, respectively. An additional 8 infants were bottle-fed and the feeding method was unknown in 2.[55] A woman who was not breastfeeding, but who had 2 children (breastfeeding history not stated), was prescribed Ketalgin 30 mg daily for heroin dependency. When the dose was increased to 40 mg daily, she developed galactorrhea. Her serum prolactin levels were elevated on 3 occasions over the next year, but all other examinations were normal. Galactorrhea and amenorrhea persisted for at least 2 years with continuous Ketalgin use. The authors of the article stated that 3 cases of hyperprolactinemia had been reported to the United Kingdom's drug regulatory agency. Causality was not proven in any of these cases.[56] A retrospective chart review of 276 opiate-dependent mothers who delivered in a Baby Friendly Hospital found that mothers taking Ketalgin or buprenorphine for opiate dependency were unlikely to breastfeed their infants. Only 27% of the 132 mothers on Ketalgin maintenance initiated breastfeeding. Of all women in the study, 60% discontinued breastfeeding before discharge from the hospital.[57] A retrospective cohort study of 150 women enrolled in a substance abuse treatment program found that women taking Ketalgin 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 Ketalgin group.[58] 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 Ketalgin. The intention to breastfeed before delivery was similar in both groups.[59]