Is Endone (oxycodone) safe to use while breastfeeding?

Safety of Endone (Oxycodone) During Breastfeeding

Endone (oxycodone) should be avoided during breastfeeding when possible, as it poses a greater risk of causing infant sedation than other analgesics and breastfed infants may receive >10% of a therapeutic dose through breast milk. 1

Risks of Oxycodone During Breastfeeding

Oxycodone presents several significant concerns for breastfeeding mothers and their infants:

• Breastfed infants may receive >10% of a therapeutic dose through breast milk 1, 2
• Oxycodone concentrates in human breast milk with a median milk-to-plasma ratio of 3.2:1 2
• Risk of infant sedation is dose-related and higher than with other analgesics 1
• Multiple case reports document sedation, respiratory depression, and feeding difficulties in infants exposed to oxycodone via breast milk 1
• Risk is particularly high at doses >30 mg/day 1, 3
• Maternal metabolism varies significantly due to CYP2D6 genetic polymorphism 1, 4:
  • Poor metabolizers may have decreased clearance of oxycodone
  • Ultrarapid metabolizers produce higher concentrations of the more potent metabolite oxymorphone

Clinical Evidence of Adverse Effects

Research demonstrates concerning outcomes for infants exposed to oxycodone through breast milk:

• A study comparing breastfeeding mothers taking different analgesics found a 20.1% rate of central nervous system depression in infants exposed to oxycodone compared to only 0.5% in those exposed to acetaminophen 5
• Mothers of infants showing symptoms took significantly higher doses of medication 5
• The FDA label warns that "withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped" 6

Recommendations for Pain Management in Breastfeeding Mothers

First-line options (preferred):

1. Non-pharmacological approaches 7:

   • Exercise therapy, yoga, tai chi
   • Application of superficial heat
   • Massage therapy and acupuncture
   • Proper breastfeeding positioning with support

2. Safer pharmacological options 1, 7:

   • Paracetamol (acetaminophen) - minimal transfer to breast milk
   • Ibuprofen - minimal transfer to breast milk
   • Other NSAIDs (diclofenac, naproxen, ketorolac) - low levels in breast milk

If stronger analgesia is required:

• Morphine is the preferred opioid when stronger analgesia is necessary 1, 7
• If oxycodone must be used:
  • Limit to single doses intra-operatively 1
  • Monitor infant for sedation after breastfeeding 1
  • Avoid doses >30 mg/day 1, 3
  • Avoid repeated dosing 1

Monitoring Recommendations

If oxycodone must be used, the infant should be closely monitored for:

• Sedation
• Respiratory depression
• Decreased alertness
• Feeding difficulties
• Signs of withdrawal if medication is discontinued 6

Important Considerations

• Short-term use (2-3 days) poses minimal risk due to low volumes of breast milk ingested during this period 2, 4
• Newly initiated and prolonged maternal opioid therapy requires close monitoring of opioid-naive infants 4
• Inadequate pain control can inhibit breastfeeding and have other negative consequences 3
• The developmental benefits of breastfeeding should be weighed against potential risks of medication exposure 6

In conclusion, while short-term, low-dose use of oxycodone may be acceptable in some circumstances with proper monitoring, safer alternatives should be prioritized whenever possible for breastfeeding mothers requiring pain management.