Am J Obstet Gynecol 2022 Jan 12. Epub 2022 Jan 12.
Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL; Center for Drug Evaluation and Safety (CoDES), University of Florida, Gainesville, FL; Department of Epidemiology, College of Medicine and College of Public Health and Health Professions, University of Florida, Gainesville, FL. Electronic address:
Background: Prevention of prenatal exposures to teratogenic drugs is a significant clinical and public health concern. With the enactment of the US Food and Drug Administration Amendments Act in 2007, the US Food and Drug Administration has begun to require manufacturers to implement Risk Evaluation and Mitigation Strategies to prevent prenatal exposures. Among 12 risk evaluation and mitigation strategy drugs, several had predecessor risk mitigation plans (eg, isotretinoin) and some were newly required (eg, mycophenolate). Read More