Psychopharmacology and Pregnancy: The New Labeling Changes and Implications for Clinical Practice
Marlene P. Freeman, MD, Massachusetts General Hospital
Almost one-half of pregnancies in the United States are unplanned and many women have experienced psychiatric illness before pregnancy. Therefore, clinicians need to consider the reproductive safety profile of psychotropics when treating women of reproductive age. The FDA letter categories for pregnancy risk often were based on animal, not human, data, and didn’t address the risk of untreated psychiatric illness or the context in which psychotropics are clinically necessary. New FDA labeling changes that were rolled out in 2015 are focused on human data, includes information about background rates of adverse events during pregnancy, and will be updated as new information becomes available in postmarketing studies (older letter-based categories will be phased out).
