Pregnancy and perinatal outcomes in migraineurs using sumatriptan: a prospective study

Background: Sumatriptan is an acute treatment for migraine which is often u sed by women in their childbearing years, and who become unexpectedly pregn ant. Within the context of the post-marketing use of sumatriptan injection for the acute treatment of migraine,and in compliance with approved labelin g, we wished to compare perinatal pregnancy outcomes in women who did and d id not use the drug after conception. Methods: Open-label, prospective stud y conducted in 12,339 migraineurs (including 9,861 women) whose demography and consumption pattern of sumatriptan injections were typical, and were pr edicted to include 150 pregnancies. Outcome of pregnancy was the end-point. Results: There were 168 of 173 pregnancies that were well-documented. Suma triptan was only used prior to conception in 92 cases. There were 76 first trimester exposures to sumatriptan. There were no differences in pregnancy outcome between the two groups. Conclusions: Perinatal and pregnancy outcom e did not differ between patients who had and had not used sumatriptan afte r conception, at the resolution of these sample sizes. This study design co mplements the ongoing pregnancy registry, which is now widened to patients exposed to all formulations of sumatriptan.