What are the precautions for breastfeeding while taking Oxycodone (OxyContin)?

From the Guidelines

Oxycodone should be used with caution during breastfeeding, with a maximum daily dose of 30 mg, and mothers should monitor their infant for signs of sedation, respiratory depression, and difficulty feeding. According to the most recent guideline on anesthesia and sedation in breastfeeding women 1, oxycodone may pose a greater risk of causing infant sedation than other drugs, and this risk is dose-related. The study highlights that breastfed infants may receive more than 10% of a therapeutic dose, leading to potential adverse effects.

When considering pain management after childbirth, alternatives like acetaminophen or ibuprofen should be considered first when possible 1. If oxycodone is necessary, timing feeds before taking the medication or waiting 2-3 hours after a dose can minimize infant exposure. Key points to consider include:

• Monitoring the infant for excessive sleepiness, difficulty feeding, breathing problems, or limpness
• Avoiding extended-release formulations due to prolonged exposure
• Informing the healthcare provider that you are breastfeeding before taking oxycodone
• Being aware that the infant's risk increases with higher maternal doses, longer duration of treatment, and in premature or newborn babies whose systems cannot metabolize medications efficiently.

Given the potential risks, it is essential to weigh the benefits and risks of oxycodone use during breastfeeding and to prioritize the infant's safety and well-being 1.

From the FDA Drug Label

Oxycodone is present in breast milk. Published lactation studies report variable concentrations of oxycodone in breast milk with administration of immediate-release oxycodone to nursing mothers in the early postpartum period. The lactation studies did not assess breastfed infants for potential adverse reactions Lactation studies have not been conducted with oxycodone hydrochloride tablets, and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for oxycodone hydrochloride tablets and any potential adverse effects on the breastfed infant from oxycodone hydrochloride tablets or from the underlying maternal condition Clinical Considerations Infants exposed to oxycodone hydrochloride tablets through breast milk should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped or when breast-feeding is stopped.

Oxycodone and Breastfeeding Precautions:

• Key Considerations: Oxycodone is present in breast milk, and infants exposed to it through breast milk should be monitored for excess sedation and respiratory depression.
• Potential Risks: Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped or when breast-feeding is stopped.
• Recommendations: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for oxycodone hydrochloride tablets and any potential adverse effects on the breastfed infant 2.

From the Research

Oxycodone and Breastfeeding Precautions

• Oxycodone is an opioid that requires caution when used during breastfeeding due to its potential for severe adverse effects 3, 4.
• The safety of maternal drug therapy during breastfeeding can be assessed by estimating the levels of drug exposure to the infant through milk 3.
• Pharmacokinetic principles predict that drugs with low clearance, such as oxycodone, may cause higher infant exposure levels 3.
• Individual variations in drug clearance among mothers and infants can lead to drug accumulation over time, even with small estimated doses 3.
• Opioid use for pain management during labor and delivery, and short-term use for 2-3 days, are generally compatible with breastfeeding 3.
• However, newly initiated and prolonged maternal opioid therapy require close monitoring of the infant 3.
• Treatment duration of newly initiated opioids in the postpartum period should be limited to 2-3 days in unsupervised outpatient settings until more safety data become available 3.

Metabolism and Transfer of Oxycodone

• Oxycodone is metabolized by the enzyme CYP2D6, which can lead to genetic polymorphisms and variations in maternal metabolism 4.
• The transfer of oxycodone from blood to milk can be affected by various factors, including the characteristics of the drug and the maternal metabolism 4.
• The evidence suggests that short-term maternal use of prescription opioids, including oxycodone, is usually safe and infrequently presents a hazard to the newborn 4.

Risk Factors for Opioid-Related Adverse Events

• Patient risk factors for opioid-related adverse drug events, including oxycodone, include comorbidities, concurrent use of sedatives, and prior opioid exposure 5.
• Advanced age, male gender, and comorbidities such as chronic obstructive pulmonary disease and neurologic disorders can also increase the risk of opioid-related adverse events 5.
• Successful identification of patient risk factors can benefit clinicians when deciding on the appropriateness of opioid therapy in hospital patients 5.