An Imperfect Literature and Evidence-Based Medicine

Two original articles comprise our Focus on Women’s Mental Health section this month. In their article, "Selective Serotonin Reuptake Inhibitor Exposure During Early Pregnancy and the Risk of Fetal Major Malformations: Focus on Paroxetine," Gentile and Bellantuono address an important clinical topic that has been the focus of many articles and media attention. A few reports regarding the risks of early antenatal exposure to selective serotonin reuptake inhibitors have raised concerns regarding possible rare malformations, but replication of such findings are generally lacking, and findings of risk are inconsistent and do not as a whole elucidate patterns that would support teratogenic effects. In particular, a registry from GlaxoSmithKline suggested an increased risk of cardiovascular malformations with paroxetine use in pregnancy (unpublished data), a finding that not surprisingly raised concerns about its use in pregnancy among health care providers and the public.