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Esomeprazole / naproxen Pregnancy and Breastfeeding Warnings

Esomeprazole / naproxen is also known as: Vimovo

Medically reviewed by Drugs.com. Last updated on Jan 5, 2021.

Esomeprazole / naproxen Pregnancy Warnings

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

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

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.
-NSAID use is not recommended in women attempting to conceive as it may impair female fertility.

Animal studies with esomeprazole have failed to reveal evidence of teratogenicity; however, decreased fetal weight and an increased incidence of minor skeletal anomalies occurred at maternotoxic doses.

The use of cyclooxygenase or prostaglandin synthesis inhibitors, including naproxen, may impair fertility and is not recommended in women attempting to conceive. Discontinuation of naproxen should be considered in women who have difficulty conceiving or are undergoing investigation of infertility.

Starting at 30 weeks gestation, naproxen, and other NSAIDs, should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. Naproxen can cause fetal harm when administered to a pregnant woman starting at 30 weeks gestation. If this drug is used during this time period in pregnancy, the patient should be apprised of the potential hazard to a fetus.

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.

Animal studies with esomeprazole magnesium revealed changes in bone morphology in offspring of rats dosed through most of the pregnancy and lactation with doses equal to or greater than approximately 33.6 times an oral human dose of 40 mg.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

See references

Esomeprazole / naproxen Breastfeeding Warnings

There are no data on the excretion of esomeprazole into human milk. The naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma. There are possible adverse effects of prostaglandin-inhibiting drugs on neonates. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

AU, UK: Use is not recommended.
US: Caution is recommended.

Excreted into human milk: Unknown (esomeprazole); Yes (naproxen)
Excreted into animal milk: Yes (esomeprazole)

The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. 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]):
  4. "Product Information. VIMOVO (esomeprazole-naproxen)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

References for breastfeeding information

  1. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Jamali F, Stevens DR "Naproxen excretion in milk and its uptake by the infant." Drug Intell Clin Pharm 17 (1983): 910-1
  5. "Product Information. VIMOVO (esomeprazole-naproxen)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.
  6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  7. Jamali F, Tam YK, Stevens RD "Naproxen excretion in breast milk and its uptake by suckling infant." Drug Intell Clin Pharm 16 (1982): 475

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.