Treximet and Pregnancy
In studies on Treximet (sumatriptan/naproxen sodium) and pregnancy, the medication increased the risk of death to the embryo, low fetal body weight, and birth defects when it was given to pregnant rabbits. Taking naproxen (a component of Treximet) during the third trimester of pregnancy can also delay labor and delivery. If you are taking Treximet and pregnancy occurs, contact your healthcare provider immediately.
Treximet™ (sumatriptan/naproxen sodium) is a prescription migraine medication. Based on animal studies, it may not be safe for use in pregnant women, although the benefits of Treximet may outweigh the risks for some women.
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Treximet was given a pregnancy Category C rating based on studies in pregnant animals. For example, when Treximet was given to pregnant rabbits during pregnancy, there was an increase in deaths to the developing embryo and an increase in low fetal body weight. Birth defects, including heart and vertebrae defects, were also seen.
In general, nonsteroidal anti-inflammatory drugs (NSAIDS) -- including naproxen (one of the components of Treximet) -- are not recommended during the third trimester, since they can delay labor and delivery and can cause certain heart problems when used late in pregnancy.
It is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if a healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.