Monitoring birth outcomes in the Sumatriptan Pregnancy Registry.
Background: Health professionals often need to make medical management decisions by weighing potential risk versus benefit. Because 50% of pregnancies in the United States are unplanned, the likelihood for unintentional first-trimester exposure to medications is high and increases when women of childbearing potential (ages 15-44) are taking medications used to treat chronic or recurrent conditions, such as migraine. Prospective collection of pregnancy exposure and outcome data is one method for providing data to the medical community as a tool for making risk assessments.Methods: The Sumatriptan Pregnancy Registry is an international, exposure-registration and follow-up study to prospectively collect prenatal sumatriptan exposure and outcome data. An advisory committee reviews data and assists in disseminating information. Committee members include independent scientists with expertise in obstetrics, pediatrics, neurology, internal medicine, epidemiology, clinical genetics, and teratology.Results: As of April 30, 1997, 181 outcomes were prospectively reported from pregnancies involving use of sumatriptan. Of the 171 outcomes where earliest exposure was in the first trimester there were 143 infants without birth defects, 4 live infants with birth defects, 1 stillbirth with birth defects [12 spontaneous pregnancy losses, 2 stillbirths, and 9 induced abortions without birth defects]. The proportion of outcomes involving birth defects, 5/148, 3.4% (95% CI 1.3%, 8.1%), does not differ from the expected proportion in the general population.Conclusions: To date, no pattern has emerged in either the prospectively or retrospectively reported defects. Registry data are disseminated to interested health care providers who are then in a more informed position when making medical management decisions. However, more data are needed before definitive conclusions can be drawn about the safety of sumatriptan use in pregnancy.
Eldridge
RR
Glaxo Wellcome, Research Triangle Park, North Carolina, USA
Ephross
SA