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
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.
Naproxen has been assigned to pregnancy category C by the FDA. 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 Breastfeeding Warnings
Naproxen is excreted into human milk in very small amounts. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants (prostaglandin-inhibiting effect on neonates), the use in nursing women should be avoided.
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 post-dose 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 post-dose period.
- Naproxen use while Breastfeeding (in more detail)
- Naproxen Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
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