A new study looking at pregnant women taking antidepressant medication, has found links in birth defects and women who took antidepressants that contain either fluoxetine or paroxetine when pregnant.
Over 28,000 woman were part of the study, which found fluoxetine use (found in multiple brands) saw an increase in heart wall defects and craniosynostosis ― and paroxetine use (found in multiple brands) saw an increase in heart defects, anencephaly, and abdominal wall defects.
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The latest study on the risk for birth defects in women taking selective serotonin reuptake inhibitors (SSRIs) early in pregnancy provides “reassuring” evidence for some antidepressants in this class but not others.
The study of nearly 28,000 women found no increased risk for birth defects linked to citalopram (Celexa, Forest Laboratories, Inc), escitalopram (Lexapro, Forest Laboratories, Inc), and sertraline (Zoloft, Pfizer Inc) but confirmed two previously reported birth defects associated with fluoxetine (multiple brands) ― heart wall defects and craniosynostosis ― and five previously reported birth defects associated with paroxetine (multiple brands), including heart defects, anencephaly, and abdominal wall defects.
Although these birth defects occurred 2 to 3.5 times more frequently among infants of women taking paroxetine or fluoxetine early in pregnancy, the absolute risk is low, the researchers note.
The study was published online July 8 in the BMJ.
“This paper should be helpful to healthcare providers because it combines the knowledge from the literature with data from one of the largest studies able to look at these issues, the National Birth Defects Prevention Study,” first author Jennita Reefhuis, PhD, epidemiologist with the National Center on Birth Defects and Developmental Disabilities at the Centers for Disease Control and Prevention, told Medscape Medical News.
“Early pregnancy is a critical time for a baby’s organs to develop, so the best time to discuss the safety of medication use is before pregnancy. If healthcare providers are treating women who are already pregnant, it is important to discuss the risk and benefits of antidepressants as well as the safest options available to treat their mental health condition during pregnancy,” Dr Reefhuis said.
SSRIs are widely used by women of childbearing age and during pregnancy. Reports of an association between paroxetine and heart defects prompted the US Food and Drug Administration to issue a safety alert in 2005.
“Recent meta-analyses and systematic reviews combining data from more than 20 epidemiological studies have reached conflicting conclusions and this uncertainty influences perceptions of the safety of antidepressant use in pregnancy,” the investigators write.
To get a more precise estimate of the potential risk for birth defects with specific SSRIs, they used bayesian methods to combine independent study findings with those from the National Birth Defects Prevention Study (NBDPS). The final analysis included 17,952 mothers of infants with birth defects and 9857 mothers of infants without birth defects.
The analysis confirmed previously reported ties between right ventricular outflow tract obstruction (RVOTO) cardiac defects in infants and maternal use of fluoxetine or paroxetine in the month prior to conception through the first trimester, and between anencephaly or atrial septal defects and use of paroxetine.