Anick Bérard1, Jin-Ping Zhao2, Odile Sheehy3. 1. Research Center, Sainte-Justine Hospital, and Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada. Electronic address: anick.berard@umontreal.ca. 2. Research Center, Sainte-Justine Hospital, and Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada. 3. Research Center, Sainte-Justine Hospital, Montreal, Quebec, Canada.
Abstract
OBJECTIVE: Given the current debate and growing public concerns on selective serotonin reuptake inhibitors (SSRIs) and birth defects generated by Food and Drug Administration warnings, we aim to quantify the association between first-trimester exposure to sertraline, a first-line treatment, and the risk of congenital malformations in a cohort of depressed women. STUDY DESIGN: This was a population-based cohort study in Quebec, Canada, 1998 through 2010. From a cohort of 18,493 depressed/anxious pregnancies, sertraline-exposed, nonsertraline SSRI-exposed, non-SSRI exposed, and unexposed (reference category) women were studied. Major malformations overall and organ-specific malformations in the first year of life were identified. Generalized estimating equation models were used to obtain risk estimates and 95% confidence intervals (CIs). Analyses were adjusted for potential confounders. RESULTS: Among the 18,493 eligible pregnancies, 366 were exposed to sertraline, 1963 to other SSRIs, and 1296 to non-SSRI antidepressants during the first trimester of pregnancy. Sertraline use was not statistically significantly associated with the risk of overall major malformations when compared to nonuse of antidepressants. However, sertraline exposure was associated with an increased risk of atrial/ventricular defects specifically (risk ratio [RR], 1.34; 95% CI, 1.02-1.76; 9 exposed cases), and craniosynostosis (RR, 2.03; 95% CI, 1.09-3.75; 3 exposed cases). Exposure to SSRIs other than sertraline during the first trimester of pregnancy was associated with craniosynostosis (RR, 2.43; 95% CI, 1.44-4.11; 19 exposed cases), and musculoskeletal defects (RR, 1.28; 95% CI, 1.03-1.58; 104 exposed cases). CONCLUSION: Sertraline use during the first trimester of pregnancy was associated with an increased risk of atrial/ventricular defects and craniosynostosis above and beyond the effect of maternal depression. Nonsertraline SSRIs were associated with an increased risk of craniosynostosis and musculoskeletal defects.
OBJECTIVE: Given the current debate and growing public concerns on selective serotonin reuptake inhibitors (SSRIs) and birth defects generated by Food and Drug Administration warnings, we aim to quantify the association between first-trimester exposure to sertraline, a first-line treatment, and the risk of congenital malformations in a cohort of depressedwomen. STUDY DESIGN: This was a population-based cohort study in Quebec, Canada, 1998 through 2010. From a cohort of 18,493 depressed/anxious pregnancies, sertraline-exposed, nonsertraline SSRI-exposed, non-SSRI exposed, and unexposed (reference category) women were studied. Major malformations overall and organ-specific malformations in the first year of life were identified. Generalized estimating equation models were used to obtain risk estimates and 95% confidence intervals (CIs). Analyses were adjusted for potential confounders. RESULTS: Among the 18,493 eligible pregnancies, 366 were exposed to sertraline, 1963 to other SSRIs, and 1296 to non-SSRI antidepressants during the first trimester of pregnancy. Sertraline use was not statistically significantly associated with the risk of overall major malformations when compared to nonuse of antidepressants. However, sertraline exposure was associated with an increased risk of atrial/ventricular defects specifically (risk ratio [RR], 1.34; 95% CI, 1.02-1.76; 9 exposed cases), and craniosynostosis (RR, 2.03; 95% CI, 1.09-3.75; 3 exposed cases). Exposure to SSRIs other than sertraline during the first trimester of pregnancy was associated with craniosynostosis (RR, 2.43; 95% CI, 1.44-4.11; 19 exposed cases), and musculoskeletal defects (RR, 1.28; 95% CI, 1.03-1.58; 104 exposed cases). CONCLUSION:Sertraline use during the first trimester of pregnancy was associated with an increased risk of atrial/ventricular defects and craniosynostosis above and beyond the effect of maternal depression. Nonsertraline SSRIs were associated with an increased risk of craniosynostosis and musculoskeletal defects.
Authors: Casey R Tak; Kathleen M Job; Katie Schoen-Gentry; Sarah C Campbell; Patrick Carroll; Maged Costantine; Diana Brixner; Angela K Birnbaum; Catherine M T Sherwin Journal: Eur J Clin Pharmacol Date: 2017-06-09 Impact factor: 2.953
Authors: Meera Viswanathan; Jennifer Cook Middleton; Alison M Stuebe; Nancy D Berkman; Alison N Goulding; Skyler McLaurin-Jiang; Andrea B Dotson; Manny Coker-Schwimmer; Claire Baker; Christiane E Voisin; Carla Bann; Bradley N Gaynes Journal: Psychiatr Res Clin Pract Date: 2021-05-04
Authors: Deidra A Ansah; Benjamin E Reinking; Tarah T Colaizy; Robert D Roghair; Sarah E Haskell Journal: Neonatology Date: 2019-03-05 Impact factor: 4.035
Authors: Sue Jordan; Joan K Morris; Gareth I Davies; David Tucker; Daniel S Thayer; Johannes M Luteijn; Margery Morgan; Ester Garne; Anne V Hansen; Kari Klungsøyr; Anders Engeland; Breidge Boyle; Helen Dolk Journal: PLoS One Date: 2016-12-01 Impact factor: 3.240
Authors: Aizati N A Daud; Jorieke E H Bergman; Wilhelmina S Kerstjens-Frederikse; Henk Groen; Bob Wilffert Journal: Int J Mol Sci Date: 2016-08-13 Impact factor: 5.923