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Morphine / naltrexone Pregnancy and Breastfeeding Warnings

Brand names: Embeda

Morphine / naltrexone Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: Based on animal data, pregnant women should be advised of a potential risk to the fetus; prolonged use of opioid analgesics during pregnancy for medical or nonmusical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.

-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. Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome. There are no adequate and well-controlled studies in pregnant women.

Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Morphine / naltrexone Breastfeeding Warnings

Morphine is excreted into breast milk with milk to plasma ratio of approximately 2.5 to 1 reported with the one of the immediate-release products. 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. Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in the breastfed infant, patients should be advised that breastfeeding is not recommended.

Not Recommended

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.

See references

References for pregnancy information

  1. Product Information. Embeda (morphine-naltrexone). King Pharmaceuticals Inc. 2009.

References for breastfeeding information

  1. Product Information. Embeda (morphine-naltrexone). King Pharmaceuticals Inc. 2009.
  2. United States National Library of Medicine. Toxnet. Toxicology Data Network. 2013.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.