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Naproxen Pregnancy and Breastfeeding Warnings

Naproxen is also known as: Aflaxen, Aleve, All Day Pain Relief, All Day Relief, Anaprox, Anaprox-DS, Comfort Pac with Naproxen, EC-Naprosyn, Flanax Pain Reliever, Leader Naproxen Sodium, Midol Extended Relief, Naprelan, Naprosyn, Naproxen Sodium DS, Pamprin All Day Relief

Naproxen Pregnancy Warnings

Animal studies have revealed evidence of an increased risk of miscarriage, pre- and post-implantation loss, gastroschisis, embryo-fetal lethality, and cardiac malformation following use of prostaglandin synthesis inhibitors in early pregnancy. Administration of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy may cause significant adverse effects, including premature closure of the fetal ductus arteriosus, pulmonary hypertension, fetal renal impairment, oligohydramnios, and inhibition of platelet aggregation. There are no controlled data in human pregnancy. Administration during labor and delivery is not recommended; onset of labor may be delayed and duration increased with greater bleeding tendency in mother and child. NSAIDs may impair female fertility; withdrawal of NSAID therapy should be considered in women with difficulties conceiving or who are undergoing investigation of infertility. 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.

Not recommended during last trimester of pregnancy. Prior to 30 weeks gestation: Use only if potential benefit justifies the potential risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C Comments: -Avoid use during third trimester as it may cause premature closure of the ductus arteriosus. -Not recommended in women attempting to conceive as may impair female fertility.

See references

Naproxen Breastfeeding Warnings

Use should be avoided. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown.

This drug has been found in the milk of lactating women at concentrations of approximately 1% of that found in plasma. Due to the long half-life and potential for serious adverse events in breastfed infants, other agents may be preferred.

See references

References for pregnancy information

  1. "Product Information. Anaprox (naproxen)." Roche Laboratories, Nutley, NJ.
  2. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."
  3. "Product Information. Naprosyn (naproxen)." Syntex Laboratories Inc, Palo Alto, CA.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. "Product Information. Naprelan 375 (naproxen)." Shionogi USA Inc, Florham Park, NJ.

References for breastfeeding information

  1. "Product Information. Naprelan 375 (naproxen)." Shionogi USA Inc, Florham Park, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Anaprox (naproxen)." Roche Laboratories, Nutley, NJ.
  4. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. "Product Information. Naprosyn (naproxen)." Syntex Laboratories Inc, Palo Alto, CA.
  7. 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 -]):

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