Naproxen / sumatriptan Pregnancy and Breastfeeding Warnings

Brand names: Treximet

Medically reviewed by Drugs.com. Last updated on May 11, 2022.

Naproxen / sumatriptan Pregnancy Warnings

Limit dose and duration of use between 20 and 30 weeks gestation; avoid use at 30 weeks gestation and later

US FDA pregnancy category: Not assigned

Risk Summary: Use of nonsteroidal anti-inflammatory drugs (NSAIDs) in pregnant women at 30 weeks gestation and later may cause premature closure of the fetal ductus arteriosus and should be avoided; NSAID use at 20 weeks gestation or later may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID in the first or second trimesters of pregnancy are inconclusive.

Comments:
-If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, use should be limited to the lowest effective dose and shortest duration possible; ultrasound monitoring of amniotic fluid should be considered if use extends beyond 48 hours; discontinue if oligohydramnios occurs and follow up according to clinical practice.

In animal studies with sumatriptan and/or naproxen during pregnancy, developmental toxicity (increased incidences of fetal malformations, embryofetal and pup mortality and decreased embryofetal growth) was observed at clinically relevant doses. A pregnancy registry active from January 1996 to September 2012, reported no major birth defects among 6 pregnancy exposures to this combination drug. Unfortunately, the number of exposed pregnancy outcomes accumulated during the registry was insufficient to support definitive conclusions about overall malformation risk or to support making comparisons of the frequencies of specific birth defects. There are no adequate and well-controlled studies in pregnant women with this combination drug. Naproxen-containing products should not be used during the third trimester of pregnancy because, like all NSAIDs, it may cause premature closure of the ductus arteriosus. Naproxen-containing products are not recommended in labor and delivery as prostaglandin inhibition may adversely affect fetal circulation and inhibit uterine contractions increasing the risk of uterine hemorrhage. The US FDA recommends pregnant women avoid NSAID use at 20 weeks gestation or later because use has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Naproxen / sumatriptan Breastfeeding Warnings

Naproxen has been found in breastmilk at approximately 1% of maximal naproxen concentrations in plasma. Sumatriptan is excreted in human milk following subcutaneous administration. Some authorities believe withholding breastfeeding for 8 hours after a single subcutaneous injection would virtually eliminate infant exposure. Limited data suggest naproxen adverse effects in breastfed infants are uncommon, but the long half-life of this drug and potentially serious adverse reactions that may occur may make other agents preferable, especially in newborn and preterm infants.

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after maternal dosing.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.

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Further information

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