Is Percocet (oxycodone and acetaminophen) safe during pregnancy?

From the Guidelines

Percocet is not recommended for use during pregnancy due to the potential risks to the developing fetus, including neonatal opioid withdrawal syndrome and birth defects. When considering pain management during pregnancy, it's essential to prioritize the health and safety of both the mother and the fetus. According to the study by 1, analgesic drug use in pregnancy can have implications for neurodevelopmental outcomes, highlighting the need for cautious use of medications like Percocet. The study by 1 also emphasizes the importance of careful pain management during pregnancy, recommending non-opioid options like NSAIDs and acetaminophen as first-line treatments, with opioids considered only for severe pain that is not managed effectively by non-opioid options. Key points to consider include:

• Non-medication approaches like physical therapy, massage, or heat therapy should be considered first for pain management during pregnancy.
• If medication is necessary, acetaminophen alone (without the opioid component) is generally considered safer for occasional use during pregnancy, but should be used at the lowest effective dose for the shortest time necessary.
• Opioids like Percocet should only be considered for severe pain that is not managed effectively by non-opioid options, and under close supervision by an obstetrician.
• Regular opioid use during pregnancy can lead to maternal dependence and increase the risk of neonatal opioid withdrawal syndrome.
• The study by 1 found associations between prenatal acetaminophen exposure and increased risk of ADHD and ASD outcomes, further emphasizing the need for cautious use of medications during pregnancy. Overall, the potential risks associated with Percocet use during pregnancy outweigh any potential benefits, and alternative pain management options should be prioritized to ensure the best possible outcomes for both mother and fetus.

From the FDA Drug Label

8 USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. ( 8.1) 8.1 Pregnancy Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5. 4)] . Available data with oxycodone hydrochloride tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. 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.

Percocet Safety in Pregnancy:

• Key Points:
  • Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome.
  • Available data are insufficient to inform a drug-associated risk for major birth defects and miscarriage.
  • Animal studies did not reveal evidence of teratogenicity or embryo-fetal toxicity.
• Clinical Decision: Percocet is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate 2, 2.
• Precautions:
  • Monitor neonates for symptoms of neonatal opioid withdrawal syndrome.
  • Advise pregnant women of the potential risk to a fetus.

From the Research

Opioid Use in Pregnancy

• Opioid use in pregnant and postpartum individuals is not rare, and obstetric providers may elect to assume opioid prescribing 3.
• Understanding indications for ongoing opioid use in pregnancy is essential to patient-centered care, and recognition of the nuanced differences between opioid dependence and opioid use disorder is crucial for appropriate diagnosis and management 3.

Neonatal Abstinence Syndrome (NAS)

• NAS results from acute discontinuation of transplacental opioid exposure following delivery in the setting of maternal opioid use, and a rise in the incidence of NAS coincides with the nationwide opioid epidemic 4.
• Infants exposed to opioids in-utero will often develop a collection of withdrawal signs known as NAS, and the incidence of NAS has substantially increased in recent years 5.
• Anywhere from 55% to 94% of infants exposed to opioids will experience withdrawal, known as NAS, and will require management of their symptoms in the hospital 6.

Management of NAS

• Non-pharmacologic interventions, standardization of traditional protocols, and alternative treatment approaches were all associated with improved outcomes in infants with NAS 7.
• Lengths of stay were generally lowest in the studies of non-pharmacologic interventions, and patients exposed to buprenorphine in utero tended to have better short-term outcomes than those exposed to methadone 7.
• Breast-feeding is encouraged in the absence of ongoing illicit or polysubstance use or infectious concerns, and infants with NAS are at risk for long-term mental and physical health problems 4.

Percocet Use in Pregnancy

• There is no direct evidence in the provided studies regarding the safety of Percocet use in pregnancy.
• However, the studies suggest that opioid use in pregnancy can lead to NAS in infants, and that non-pharmacologic interventions and standardized care plans can improve outcomes for infants with NAS 3, 4, 5, 6, 7.