title: Recent changes in pregnancy and lactation labeling: retirement of risk categories.
abstract: The rapid development and increased availability of novel pharmacologic therapies and pharmaceutical products has amplified the potential for drug exposure during pregnancy. Many drugs are beneficial for disease state management during pregnancy and provide significant fetal and maternal health benefits. However, a paucity of safety data combined with the imprecision of the current risk category system renders risk versus benefit assessment difficult. In response to decades of criticism, the U.S. Food and Drug Administration (FDA) is implementing a new pregnancy and lactation labeling rule designed to improve risk versus benefit assessment of drugs used in pregnant and nursing mothers. These recommendations will provide clear and detailed information for both patients and health care providers, and they will include three main categories: risk summary, clinical considerations, and data. The new labeling rules remove the previous letter risk categorization system (A, B, C, D, X). In this review, we summarize the upcoming FDA labeling changes and discuss their potential consequences on clinical practice.
authors.affiliation: Temple University School of Pharmacy, Philadelphia, Pennsylvania.
authors.forename: Leda L
authors.initials: LL
authors.lastname: Ramoz
authors.forename: Nima M
authors.initials: NM
authors.lastname: Patel-Shori
mesh_terms: D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D005260:Female; D005333:Fetus / Q000187:drug effects*; D006801:Humans; D007774:Lactation / Q000187:drug effects*; D011247:Pregnancy; D012306:Risk; D014481:United States; D014486:United States Food and Drug Administration
keywords: FDA; U.S. Food and Drug Administration; labeling; lactation; pregnancy; risk categories