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Ibuprofen / oxycodone Pregnancy and Breastfeeding Warnings

Ibuprofen / oxycodone is also known as: Combunox

Medically reviewed by Drugs.com. Last updated on Nov 20, 2019.

Ibuprofen / oxycodone Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity or developmental toxicity. Prolonged use of opioids during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. The onset, duration, and severity of the condition will vary based on the specific opioid use, duration of use, timing, and amount of last maternal use, and rate of elimination in the newborn. There are no controlled data in human pregnancy.

US FDA Drug Safety Communication (10-2020): The FDA is requiring a new warning be added to NSAID labeling describing the risk of fetal kidney problems that may result in low amniotic fluid. The FDA is recommending pregnant women avoid NSAID use at 20 weeks gestation or later. Through 2017, the FDA has received 35 reports of low amniotic fluid levels or kidney problems in mothers who took NSAIDs while pregnant. Five newborns died; 2 had kidney failure and confirmed low amniotic fluid, 3 had kidney failure without confirmed low amniotic fluid. The low amniotic fluid started as early as 20 weeks of pregnancy. There were 11 reports of low amniotic fluid levels during pregnancy and the fluid volume returned to normal after the NSAID was stopped. The medical literature has reported low amniotic fluid levels with use of NSAIDs for varying amounts of time, ranging from 48 hours to multiple weeks. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. In other cases, the condition was reversible within 3 to 6 days of stopping the NSAID and in these cases reappeared when the same NSAID was restarted.

Chronic use of opioids may cause reduced fertility; it is unknown whether these effects are reversible. NSAID use may be associated with a reversible delay in ovulation.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Contraindicated last trimester of pregnancy
NSAIDs should be avoided at 20 weeks gestation and later

US FDA pregnancy category: C (prior to 30 weeks gestation)
US FDA pregnancy category: D (starting at 30 weeks gestation)

Risk Summary: Nonsteroidal anti-inflammatory drugs (NSAIDs) use in pregnant women at 30 weeks gestation and later may cause premature closure of the fetal ductus arteriosus; NSAID use at 20 weeks gestation or later may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Comments:
-NSAID use in pregnancy prior to 20 weeks gestation should be based on a benefit-risk assessment; some authorities recommend avoiding NSAIDs throughout pregnancy whenever possible.
-If NSAID use is necessary between 20- and 30-weeks' gestation, limit use to the lowest effective dose for the shortest duration possible; ultrasound monitoring of amniotic fluid should be considered if NSAID use extends beyond 48 hours; if oligohydramnios occurs, discontinue NSAID and treat appropriately.
-Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.
-Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.

See references

Ibuprofen / oxycodone Breastfeeding Warnings

Maternal use of narcotics during breastfeeding can cause infant drowsiness, central nervous system depression, and even death. Infant sedation is common with maternal use of oxycodone. Newborn infants are particularly sensitive to the effects of even small doses of narcotic analgesics. Ibuprofen use may be considered acceptable in nursing mothers; however, according to some manufacturers, use is not recommended. Limited published reports indicate ibuprofen is present in human milk at relative infant doses of 0.06% to 0.6% of the maternal weight-adjusted daily dose. When considering risk versus benefit, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug.

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-If used, monitor breastfed infants for excess sedation and respiratory depression.
-Withdrawal symptoms may occur in breastfed infants when maternal administration of an opioid is stopped or when breast-feeding is stopped.

See references

References for pregnancy information

  1. "Product Information. Ibuprofen-Oxycodone Hydrochloride (ibuprofen-oxycodone)." Actavis U.S. (Alpharma USPD), Owings Mills, MD.
  2. US Food and Drug Administration "FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid. Available from: URL: https://www.fda.gov/media/142967/download." ([2020, Oct 15]):

References for breastfeeding information

  1. "Product Information. Ibuprofen-Oxycodone Hydrochloride (ibuprofen-oxycodone)." Actavis U.S. (Alpharma USPD), Owings Mills, MD.

Further information

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