B1 Vertaisarvioimaton kirjoitus tieteellisessä lehdessä
Selective Serotonin Reuptake Inhibitors and Venlafaxine in Early Pregnancy and Risk of Birth Defects: Population Based Cohort Study and Sibling Design
Tekijät: Furu K, Kieler H, Haglund B, Engeland A, Selmer R, Stephansson O, Valdimarsdottir UA, Zoega H, Artama M, Gissler M, Malm H, Norgaard M
Kustantaja: LIPPINCOTT WILLIAMS & WILKINS
Julkaisuvuosi: 2015
Journal: Obstetrical and Gynecological Survey
Tietokannassa oleva lehden nimi: OBSTETRICAL & GYNECOLOGICAL SURVEY
Lehden akronyymi: OBSTET GYNECOL SURV
Vuosikerta: 70
Numero: 9
Aloitussivu: 553
Lopetussivu: 554
Sivujen määrä: 2
ISSN: 0029-7828
DOI: https://doi.org/10.1097/01.ogx.0000471597.68671.1e
Tiivistelmä
In North America, 4% to 10% of pregnant women take selective serotonin reuptake inhibitors (SSRIs) for depression. Some studies have reported an increased risk of congenital cardiovascular defects in the infants delivered to women who used SSRIs during pregnancy, although studies on these and other risks have yielded conflicting results. A previous study also reported that venlafaxine, a serotonin-norepinephrine reuptake inhibitor used as an alternative to SSRIs, was associated with some birth defects, but there are limitations in previous study on both SSRIs and venlafaxine, and further study is needed. The current study aimed to evaluate the association between the use of these drugs and risk of specific birth defects. The study population included women who gave birth to a live singleton in Denmark, Finland, Norway, Iceland, and Sweden between 1996 and 2010. Data came from national registries. Exposure in utero was defined as instances when a woman filed a prescription for SSRI from 30 days before the first day of her last period to 97 days after the last period. Birth defects assessed included a range of cardiovascular defects as well as anal atresia, hypospadias, clubfoot, limb reduction defects, craniosynostosis, omphalocele, gastroschisis, and cystic kidneys. Statistical analyses estimated odds ratios (ORs) for these types of birth defects and were adjusted for confounding factors including maternal age at delivery, maternal smoking during pregnancy, concurrent drug use, maternal diabetes, birth order, and country and year of delivery. A sibling-controlled analysis included 2288 singleton live births. Of a full study cohort of 2,303,647 women, 1.6% (36,772) were exposed to SSRIs or venlafaxine during the first trimester. During the study period, the rate of infants exposed to these drugs increased from 0.6% in 1996-2000 to 1.5% in 2001-2005 and then to 2.2% in 2006-2010. Of the 36,772 exposed, 1357 infants (3.7%) had a diagnosis of a major birth defect as compared with 3.2% (71,374 of 2,226,875) of unexposed infants (adjusted OR, 1.13; 95% confidence interval [CI], 1.06-1.20). In exposed infants, 1.5% had overall cardiac birth defects, whereas 1.2% of unexposed infants had diagnoses of cardiac birth defects (OR, 1.15; 95% CI, 1.05-1.26). The prevalence of birth defects was associated with in utero exposure to each specific SSRI, as well as venlafaxine, but not including escitalopram (adjusted ORs between 1.13 and 1.34). However, in the sibling cohort analysis, adjusted OR was 1.06 (95% CI, 0.91-1.24). The study did not find a substantial teratogenic effect of SSRIs or venlafaxine. Although the prevalence of some defects were higher in the group of exposed infants, the lack of association in the sibling control group suggest no substantial increase in the prevalence of birth defects among infants exposed to SSRIs or venlafaxine.
In North America, 4% to 10% of pregnant women take selective serotonin reuptake inhibitors (SSRIs) for depression. Some studies have reported an increased risk of congenital cardiovascular defects in the infants delivered to women who used SSRIs during pregnancy, although studies on these and other risks have yielded conflicting results. A previous study also reported that venlafaxine, a serotonin-norepinephrine reuptake inhibitor used as an alternative to SSRIs, was associated with some birth defects, but there are limitations in previous study on both SSRIs and venlafaxine, and further study is needed. The current study aimed to evaluate the association between the use of these drugs and risk of specific birth defects. The study population included women who gave birth to a live singleton in Denmark, Finland, Norway, Iceland, and Sweden between 1996 and 2010. Data came from national registries. Exposure in utero was defined as instances when a woman filed a prescription for SSRI from 30 days before the first day of her last period to 97 days after the last period. Birth defects assessed included a range of cardiovascular defects as well as anal atresia, hypospadias, clubfoot, limb reduction defects, craniosynostosis, omphalocele, gastroschisis, and cystic kidneys. Statistical analyses estimated odds ratios (ORs) for these types of birth defects and were adjusted for confounding factors including maternal age at delivery, maternal smoking during pregnancy, concurrent drug use, maternal diabetes, birth order, and country and year of delivery. A sibling-controlled analysis included 2288 singleton live births. Of a full study cohort of 2,303,647 women, 1.6% (36,772) were exposed to SSRIs or venlafaxine during the first trimester. During the study period, the rate of infants exposed to these drugs increased from 0.6% in 1996-2000 to 1.5% in 2001-2005 and then to 2.2% in 2006-2010. Of the 36,772 exposed, 1357 infants (3.7%) had a diagnosis of a major birth defect as compared with 3.2% (71,374 of 2,226,875) of unexposed infants (adjusted OR, 1.13; 95% confidence interval [CI], 1.06-1.20). In exposed infants, 1.5% had overall cardiac birth defects, whereas 1.2% of unexposed infants had diagnoses of cardiac birth defects (OR, 1.15; 95% CI, 1.05-1.26). The prevalence of birth defects was associated with in utero exposure to each specific SSRI, as well as venlafaxine, but not including escitalopram (adjusted ORs between 1.13 and 1.34). However, in the sibling cohort analysis, adjusted OR was 1.06 (95% CI, 0.91-1.24). The study did not find a substantial teratogenic effect of SSRIs or venlafaxine. Although the prevalence of some defects were higher in the group of exposed infants, the lack of association in the sibling control group suggest no substantial increase in the prevalence of birth defects among infants exposed to SSRIs or venlafaxine.
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