Evidence-based reference for medication use during pregnancy and lactation. Organized under the FDA Pregnancy and Lactation Labeling Rule (PLLR), effective June 30, 2015. All summaries cite primary literature.
Important: This reference is a clinical decision support tool, not a substitute for comprehensive prescribing information or individual clinical judgment. Always consult the current FDA label, LactMed, and MotherToBaby for the most complete and current information.
Evidence Base & Framework
U.S. Food and Drug Administration. Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling. Final Rule. Fed Regist. 2014;79(233):72063–72103. — Establishes the PLLR framework replacing A/B/C/D/X categories.
Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. 12th ed. Philadelphia: Wolters Kluwer; 2022. — Comprehensive drug-by-drug reference; primary source for individual drug summaries.
National Library of Medicine. LactMed: Drugs and Lactation Database. Bethesda, MD: NLM; 2023. Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/. — Peer-reviewed lactation data for individual medications.
Organization of Teratology Information Specialists (OTIS) / MotherToBaby. Fact Sheets. Available at: https://mothertobaby.org. — Evidence-based teratology fact sheets for patients and providers.
PLLR 8.1
Pregnancy
Human & animal data, risk summary, clinical considerations. Replaces old A/B/C/D/X letter categories.
PLLR 8.2
Lactation
Drug presence in breast milk, estimated infant dose, effects on milk production.
