Advise pregnant women of the potential risk to fetus

US FDA pregnancy category: Not assigned

Risk Summary: Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal; there are no available data to inform a drug-associated risk for major birth defects and miscarriage.

Comments:
-Pregnant women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.
-Naltrexone may precipitate withdrawal in the fetus due to the immaturity of the fetal blood-brain barrier.
-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 with immediate-release oxycodone during organogenesis have not revealed evidence of teratogenicity or embryo-fetal toxicity; however published studies have shown neurobehavioral effects in rat pups at clinically relevant doses. Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. During clinical trials, plasma naltrexone levels were detectable in some patients receiving this combination drug, therefore, there is a possibility that naltrexone could precipitate withdrawal in a fetus due to the immaturity of the fetal blood-brain barrier. There are no adequate well-controlled studies with this combination drug in human pregnancies.

Chronic opioid use may cause reduced fertility in males and females; it is not known whether these effects 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.

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Lactation studies are not available with this combination drug. Published information on immediate-release oxycodone has shown infant sedation is common. During clinical trials, plasma naltrexone levels were detectable in some patients receiving this combination drug and therefore, it may be possible that naltrexone could precipitate withdrawal in a breastfed infant.

Use is not recommended

Excreted into human milk: Yes (oxycodone); Yes (naltrexone)

Comments:
-Breastfed infants should be closely monitored for excess sedation and respiratory depression; prompt medical attention should be obtained if trouble breathing, increased sleepiness, difficulty breastfeeding, or limpness develops.
-Withdrawal symptoms may occur in breastfed infants when maternal administration is stopped or when breastfeeding is stopped.

See references