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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 decreased fetal body weight, an increase in embryofetal death, and an increase in the total incidences of fetal abnormalities. These fetal abnormalities included increasing incidences of specific malformations (cardiac interventricular septal defect, fused caudal vertebrae, and variations (absent intermediate lobe of the lung, irregular ossification of the skull, and incompletely ossified sternal centra). There are no controlled data in human pregnancy. Use late in pregnancy may cause premature closure of the ductus arteriosus and prolong labor and delivery. Naproxen should be avoided in the third trimester. Naproxen is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk. Naproxen cord blood levels were obtained from two twins delivered at 30 weeks gestation of a mother treated for premature labor with naproxen 250 mg every eight hours, beginning 30 hours prior to delivery. The last dose was administered five hours before delivery. Naproxen concentrations were 59.5 mcg/mL in the first twin and 68 mcg/mL in the second twin. Both infants suffered from pulmonary hypertension and required assisted ventilation. One infant died. The pulmonary hypertension was presumed to be the result of intrauterine closure of the ductus arteriosus mediated by the naproxen-induced inhibition of fetal prostaglandin synthesis. 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.

FDA pregnancy category: C Naproxen should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus.

See references

Naproxen Breastfeeding Warnings

Use of naproxen is not recommended. Excreted into human milk: Yes Prostaglandin-inhibiting drugs may have adverse effects in nursing infants.

The excretion of naproxen into breast milk was evaluated in a 23-year-old female following chronic administration of naproxen 250 mg twice a day. Milk concentrations peaked at 4 hours postdose and ranged from 1.14 to 1.25 ng/mL. Following a regimen of naproxen 375 mg twice a day, maximum milk concentrations averaged 2.37 ng/mL. Maternal and infant plasma samples were not obtained during the study. However, urine was collected from both mother and infant. The infant eliminated 0.47 mg naproxen and conjugates in the urine over a 12-hour postdose period.

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References for pregnancy information

  1. "Product Information. Anaprox (naproxen)." Roche Laboratories, Nutley, NJ.
  2. "Product Information. Treximet (naproxen-sumatriptan)." Pernix Therapeutics, Magnolia, TX.
  3. "Product Information. Naprosyn (naproxen)." Syntex Laboratories Inc, Palo Alto, CA.
  4. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
  5. Wilkinson AR, Aynsley-Green A, Mitchell MD "Persistent pulmonary hypertension and abnormal prostaglandin E levels in preterm infants after maternal treatment with naproxen." Arch Dis Child 54 (1979): 942-5
  6. Wilkinson AR "Naproxen levels in preterm infants after maternal treatment." Lancet 2 (1980): 591-2

References for breastfeeding information

  1. Jamali F, Stevens DR "Naproxen excretion in milk and its uptake by the infant." Drug Intell Clin Pharm 17 (1983): 910-1
  2. Mason L, Edwards JE, Moore RA, McQuay HJ "Single-dose oral naproxen for acute postoperative pain: a quantitative systematic review." BMC Anesthesiol 3 (2003): 4
  3. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  4. "Product Information. Naprosyn (naproxen)." Syntex Laboratories Inc, Palo Alto, CA.
  5. Jamali F, Tam YK, Stevens RD "Naproxen excretion in breast milk and its uptake by suckling infant." Drug Intell Clin Pharm 16 (1982): 475
  6. "Product Information. Anaprox (naproxen)." Roche Laboratories, Nutley, NJ.

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