Triptan exposure during pregnancy and the risk of major congenital malformations and adverse pregnancy outcomes: results from the Norwegian Mother and Child Cohort Study.
OBJECTIVE
To evaluate the safety of triptan therapy during pregnancy.


BACKGROUND
Information on the safety of triptan therapy during pregnancy is scarce and only available for sumatriptan, naratriptan, and rizatriptan. No associations with congenital malformations have been detected so far, but one study found a significant association between sumatriptan exposure during pregnancy and prematurity.


METHODS
The study population consisted of 69,929 pregnant women and their newborn children for whom data on drug exposure and pregnancy outcome were available. Information on triptan therapy and potential socio-demographic and medical confounding factors was obtained from the Norwegian Mother and Child Cohort Study. Information on congenital malformations and other adverse pregnancy outcomes was obtained from the Norwegian Medical Birth Registry. The datasets were linked via the women's personal identification number. Pearson's chi(2) tests and logistic regression analyses were used to identify associations between triptan therapy and pregnancy outcome.


RESULTS
No significant associations between triptan therapy during the first trimester and major congenital malformations (unadjusted OR: 1.0; 95% CI 0.8-1.3, adjusted OR: 1.0; 95% CI 0.7-1.2) or other adverse pregnancy outcomes were found. Triptan therapy during the second and/or third trimesters was significantly associated with atonic uterus (unadjusted OR: 1.5; 95% CI 1.1-1.9, adjusted OR: 1.4; 95% CI 1.1-1.8), and blood loss >500 mL during labor (unadjusted OR: 1.3; 95% CI 1.1-1.5, adjusted OR: 1.3; 95% CI 1.1-1.5).


CONCLUSIONS
Triptan therapy during pregnancy was not associated with an overall increased risk of congenital malformations. It cannot, however, be excluded that a difference in the risk between triptan use and individual or rare congenital malformations may exist. A slight increase in the risk of atonic uterus and hemorrhage was associated with triptan use during the second and/or third trimesters. Although the present findings are reassuring, confirmation in independent studies is warranted.
Nezvalová-Henriksen
Katerina
K
Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, Norway.
Spigset
Olav
O
Nordeng
Hedvig
H
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D000293:Adolescent; D000328:Adult; D015984:Causality; D015331:Cohort Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D008881:Migraine Disorders / Q000188:drug therapy; D009664:Norway / Q000453:epidemiology; D011247:Pregnancy; D011248:Pregnancy Complications / Q000139:chemically induced* / Q000453:epidemiology*; D011261:Pregnancy Trimester, First / Q000187:drug effects; D011297:Prenatal Exposure Delayed Effects / Q000139:chemically induced* / Q000453:epidemiology*; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D014363:Tryptamines / Q000009:adverse effects*; D055815:Young Adult
D014363:Tryptamines