Final Results From the 16‐Year Sumatriptan, Naratriptan, and Treximet Pregnancy Registry

Abstract

The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry detected no signal of teratogenicity associated with major birth defects for sumatriptan. This finding is consistent with results from other observational studies using a variety of control groups. Enrollment in the registry was insufficient to permit definitive conclusions of the risks associated with naratriptan or sumatriptan/naproxen sodium tablets, or to assess the risk of individual birth defects in any of the products studied. Low enrollment and high rates of loss to follow up within the registry over an extended period of time led the registry's scientific advisory committee to conclude that continuation of the registry beyond its 16 years would offer little additional power to rule out more moderate increases in the risk of birth defects. Data from the other ongoing surveillance sources constitute an important element of post-marketing surveillance of these medications. The lack of a signal of major teratogenicity with sumatriptan across these several sources of data is encouraging.

Pregnancy Outcome Following Prenatal Exposure to Triptan Medications: A Meta‐Analysis

“…Although the results of the present meta‐analysis are largely impacted by the outcomes of the 2 large studies included, they revealed that the use of triptan medications during pregnancy does not increase the rates of premature deliveries or rates of MCMs in the triptan‐exposed children when compared with healthy controls. These results are in agreement with numerous previous studies and are also supported by a 2014 report from international registries including 680 pregnancies exposed to triptans, despite the registries' potential methodological limitations and lack of comparison groups …”

Acute Migraine Treatment in Adults

“…No association between sumatriptan use in the first trimester and fetal malformations or adverse pregnancy outcomes was found in a large observational study, although sumatriptan use in the second and third trimester was associated with atonic uterus and blood loss >500 mL during labor and delivery . A pregnancy registry that included 528 pregnant women with first trimester sumatriptan exposure concluded that no signal of teratogenicity associated with major birth defects was detected . There are much less data with regard to other triptans.…”

Pharmacological treatment of migraine during pregnancy and breastfeeding

“…A total of 10 studies, including more than 6,000 exposed infants, have evaluated pregnancy outcomes after maternal triptan use. [59][60][61][62][63][64][65][66][67][68] Five of the studies included multiple triptans, whereas four studies evaluated sumatriptan only, [65][66][67][68] and one rizatriptan only. 62 The most frequently studied adverse pregnancy outcomes were spontaneous abortion, congenital malformations, prematurity or low gestational age, and low birth weight.…”