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Naproxen / sumatriptan Pregnancy and Breastfeeding Warnings

Naproxen / sumatriptan is also known as: Treximet

Medically reviewed on Sep 10, 2018

Naproxen / sumatriptan Pregnancy Warnings

Use should be avoided during last trimester of pregnancy
Prior to last trimester of pregnancy, use only if potential benefit justifies the potential risk to the fetus

US FDA pregnancy category: X during the third trimester
US FDA pregnancy category: C for first 2 trimesters

Use of sumatriptan and naproxen, alone or in combination, in animal studies during pregnancy resulted in increased incidences of fetal malformations, embryofetal and pup mortality, and decreased embryofetal growth at clinically relevant doses. There are no adequate and well-controlled studies in pregnant women. 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.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

US 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.

See references

Naproxen / sumatriptan Breastfeeding Warnings

Although limited data suggests naproxen levels in breastmilk are low and adverse effects in breastfed infants uncommon, the long half-life of this drug and potentially serious adverse reactions that may occur make other agents preferable.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

See references

References for pregnancy information

  1. "Product Information. Treximet (naproxen-sumatriptan)." Pernix Therapeutics, Magnolia, TX.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Treximet (naproxen-sumatriptan)." Pernix Therapeutics, Magnolia, TX.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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