Naproxen Pregnancy and Breast Feeding Warnings
Naproxen is also known as: Aflaxen, Aleve, Anaprox, Anaprox-DS, Comfort Pac with Naproxen, EC-Naprosyn, Leader Naproxen Sodium, Midol Extended Relief, Naprelan, Naprosyn, Naproxen Sodium DS
Overview
Naproxen Sustained-Release Tablets may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Naproxen Sustained-Release Tablets while you are pregnant. Naproxen Sustained-Release Tablets should not be used during labor. Naproxen Sustained-Release Tablets is found in breast milk. Do not breast-feed while taking Naproxen Sustained-Release Tablets.
Naproxen Pregnancy Warnings
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 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 Lactation 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.
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