Morphine / naltrexone Pregnancy and Breastfeeding Warnings

Morphine / naltrexone is also known as: Embeda

Morphine / naltrexone Pregnancy Warnings

This drug should be used during pregnancy only if the benefit clearly outweighs the risk to the fetus. US FDA pregnancy category: C Comments: -Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available. -Long-acting opioids should not be used during and immediately prior to labor, when short acting analgesics or other analgesic techniques are more appropriate.

Animal studies have shown that morphine exposure during pregnancy is associated with growth reduction and behavioral abnormalities. Chronic morphine exposure of fetal animals showed altered reflex and motor skill development, mild withdrawal, and altered responsiveness to morphine persisting into adulthood. There are no adequate and well-controlled studies in pregnant women. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Morphine / naltrexone Breastfeeding Warnings

Morphine is excreted into breast milk with milk to plasma ratios of approximately 2.5 to 1. Newborn infants appear to be particularly sensitive to even small doses of oral narcotics with drowsiness, central nervous system depression, and even death having been reported. Naltrexone is minimally excreted into breast milk.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes (morphine); Yes (naltrexone) Comments: Breastfed infants should be closely monitored; withdrawal symptoms can occur when maternal administration of morphine is stopped.

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