FIRST-TRIMESTER USE OF SSRIs AND THE RISK OF BIRTH DEFECTS
According to the March of Dimes approximately 10% of pregnant women are affected by depression and are treated with antidepressants. Selective Serotonin Reuptake Inhibitors (SSRIs) are a class of drugs used primarily to treat depression, anxiety and some personality disorders. Common SSRIs include Prozac (fluoxetine), Celexa (citalopram), Zoloft (sertraline), Paxil (paroxetine) and Lexapro (escitalopram). Recently, the results of several studies published in the New England Journal of Medicine raised concern regarding the effects of using SSRIs while pregnant. SSRIs aside, every pregnancy has a 3% risk of a major birth defect as per the Center for Disease Control.
One study performed by Sura Alwan, M.Sc., et. al. and published in The New England Journal of Medicine’s June 28, 2007 issue refuted previous studies by concluding that “maternal use of SSRIs during early pregnancy was not associated with significantly increased risk of congenital heart defects or of most other categories of birth defects. However, the study did reveal that “associations were observed between SSRI use and three types of birth defects.” Specifically, maternal SSRI use was associated with anencephaly (a defect of the brain), craniosynostosis (a type of abnormal skull development) and omphalocele (a gastrointestinal abnormality).
Another study performed by Carol Louik, Sc.D., et. al. also published in The New England Journal of Medicine’s June 28, 2007 issue contradicted portions of Alwan’s study and previous studies as well by concluding that generally SSRI use is not linked to significantly increased risks of craniosynostosis, omphalocele, or heart defects. However, this study’s findings did “suggest that individual SSRIs may confer increased risks for some specific defects.”
Both studies revealed that although there are risks for specific defects associated with the use of SSRIs they appear to be minimal. An accompanying editorial written by Dr. Greene stated “the two reports in this issue of the Journal, together with other available information, do suggest that any increased risk of these malformations in association with the use of SSRIs are likely to be small in terms of absolute risks.” However, when the SSRIs were analyzed individually, opposed to generally as a group, the researchers discovered that a significant nexus existed between certain SSRIs and specific defects.
It is important to note that these studies conflict with previous studies involving first-trimester use of SSRIs and the risk of birth defects. Results of previous studies concluded that SSRI use (Paxil specifically) during the first trimester of pregnancy doubled the risk of atrial and ventricular septal defects prompting labeling changes and warnings issued by the FDA. Additionally, these studies did not consider the disorder known as persistent pulmonary hypertension (PPHN) which in prior studies was linked to SSRI use late in the pregnancy. Moreover, the study performed at the Slone Epidemiology Center at Boston University by Carol Louik, Sc.D., et. al. was funded in part by Paxil maker GlaxoSmithKline.
The March of Dimes suggests that “if you are taking an antidepressant and find that you are pregnant, do not stop taking your medication without first talking to your health provider. It may be unhealthy to stop taking an antidepressant suddenly.”
If you or someone you know suffers from an injury, birth defect, or other side effect, or if you have lost a loved one due to these dangers, you are not alone and you deserve answers. Make sure to contact our experienced, compassionate, and knowledgeable DrugSettlement.com birth defect lawyer by using our contact form.