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Naproxen / sumatriptan Pregnancy and Breastfeeding Warnings

Naproxen / sumatriptan is also known as: Treximet

Naproxen / sumatriptan Pregnancy Warnings

Naproxen-sumatriptan has been assigned to pregnancy category C by the FDA. Animal studies of naproxen sodium, both alone and in combination with sumatriptan, have revealed evidence of an increase in embryofetal death and increases 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). Animal studies of sumatriptan combined with naproxen sodium or each drug alone have revealed evidence of decreased fetal body weight. There are no controlled data in human pregnancy. Use of naproxen late in pregnancy may cause premature closure of the ductus arteriosus and prolong labor and delivery. Therefore, the use of naproxen-sumatriptan should be avoided in the third trimester. Naproxen-sumatriptan is only recommended for use during the first two trimesters of pregnancy when there are no alternatives and benefit outweighs risk.

To monitor fetal outcomes of pregnant women exposed to naproxen-sumatriptan, GlaxoSmithKline maintains a Treximet Pregnancy Registry. Physicians are encouraged to register patients as soon as possible after they become pregnant and (if possible) before the outcome of the pregnancy is known by calling (800) 336-2176. 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. One review article has stated that "Available literature to date indicates that exposure to sumatriptan during pregnancy has no additional risk of birth defects compared with the incidence in the general population."

Naproxen / sumatriptan Breastfeeding Warnings

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.

Both naproxen sodium and sumatriptan have been reported to be excreted in breast milk. Because of the possible adverse effects of these drugs on neonates, the manufacturer recommends that the use of naproxen-sumatriptan be avoided in nursing mothers.

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