Summary of Use during Lactation

Limited information indicates that levels of naproxen in breastmilk are low and adverse effects in breastfed infants are apparently uncommon. However, because of naproxen's long half-life and reported serious adverse reaction in a breastfed neonate, other agents may be preferred while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. Peak milk naproxen levels in a 5-month postpartum patient were 1.1 to 1.3 mg/L while taking oral naproxen 250 mg twice daily and 2.4 mg/L with a dose of 375 mg twice daily. Peak milk levels occurred 4 to 5 hours after the dose and fell slowly over 12 to 24 hours. From urinary excretion data the authors estimated that the infant received 0.26% of the mother's total dose or 1.9% of the maternal weight-adjusted dosage.[1] Using the peak milk level data, the estimated maximum intake of an exclusively breastfed infant would be 2.2 to 2.8% of the maternal weight-adjusted dosage, not including the contribution of any glucuronide metabolite.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Naproxen possibly caused prolonged bleeding time, thrombocytopenia and acute anemia in one 7-day-old infant of a mother also taking bacampicillin.[3]

In one telephone follow-up study of 20 infants (ages not stated) exposed to naproxen during breastfeeding, 2 mothers reported drowsiness and 1 reported vomiting in their infants. None of the reactions required medical attention.[4]

Effects on Lactation and Breastmilk

A randomized study compared naproxen and tramadol for post-cesarean section pain. Patients received the drugs either on a fixed schedule or as needed. No difference in breastfeeding rates were seen among the groups.[5]

Alternate Drugs to Consider

Acetaminophen, Flurbiprofen, Ibuprofen, Indomethacin, Piroxicam

References

1.

Jamali F, Tam YK, Stevens RD. Naproxen excretion in breast milk and its uptake by suckling infant. Drug Intell Clin Pharm. 1982;16:475. Abstract.

2.

Jamali F, Stevens DR. Naproxen excretion in milk and its uptake by the infant. Drug Intell Clin Pharm. 1983;17:910-1. Letter. [PubMed: 6653409]

3.

Fidalgo I, Correa R, Gomez Carrasco JA et al. [Acute anemia, rectorrhagia and hematuria caused by ingestion of naproxen]. An Esp Pediatr. 1989;30:317-9. [PubMed: 2787136]

4.

Ito S, Blajchman A, Stephenson M et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. [PubMed: 8498418]

5.

Sammour RN, Ohel G, Cohen M, Gonen R. Oral naproxen versus oral tramadol for analgesia after cesarean delivery. Int J Gynaecol Obstet. 2011;113:144-7. [PubMed: 21435642]

Substance Name

Naproxen

CAS Registry Number

22204-53-1

Drug Class

• Breast Feeding
• Lactation
• Analgesic Agents
• Nonsteroidal Antiinflammatory Agents