Can I take oxycodone while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4) ] . Available data with oxycodone HCl in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes. Animal reproduction studies with oral administrations of oxycodone HCl in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectively, the human dose of 60 mg/day did not reveal evidence of teratogenicity or embryo-fetal toxicity. In several published studies, treatment of pregnant rats with oxycodone at clinically relevant doses and below, resulted in neurobehavioral effects in offspring [see Data ] . Based on animal data, advise pregnant women of the potential risk to a fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Oxycodone Hydrochloride (oral), Major Pharmaceuticals. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Maternal use of oral opioids during breastfeeding can cause infant drowsiness, which may progress to rare but severe central nervous system depression. Sedation and apnea have occurred in breastfed infants after maternal use of oxycodone. Newborn infants seem to be particularly sensitive to the effects of even small dosages of narcotic analgesics. If oxycodone is required by the mother of a newborn, it is not a reason to discontinue breastfeeding; however, once the mother's milk comes in, it is best to treat pain with a nonnarcotic analgesic and limit maternal intake of oral oxycodone (and combinations) to 30 mg daily for 2 to 3 days, especially in the outpatient setting.[1-3] Monitor the infant closely for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants. If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breastfeeding is stopped. Extended-release oxycodone products (such as OxyContin) are not recommended in nursing mothers.

“Summary of Use during Lactation”, LactMed record “Oxycodone” (LM378), quoted verbatim. Everything LactMed reports about Oxycodone while breastfeeding.

8.2 Lactation Risk Summary Available data from lactation studies indicate that oxycodone is present in breastmilk and that doses of less than 60 mg/day of the immediate-release formulation are unlikely to result in clinically relevant exposures in breastfed infants. A pharmacokinetics study utilizing opportunistic sampling of 76 lactating women receiving oxycodone immediate-release products for postpartum pain management showed that oxycodone concentrates in breastmilk with an average milk to plasma ratio of 3.2. The relative infant dose was low, approximately 1.3% of a weight-adjusted maternal dose (see Data ) . In the same study, among the 70 infants exposed to oxycodone in breastmilk, no adverse events were attributed to oxycodone.

Prescribing label, section “8.2 Lactation” (opening excerpt): Oxycodone Hydrochloride (oral), Major Pharmaceuticals. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.