Availability of Safe and Effective Therapeutic Options to Pregnant and Lactating Individuals Following the United States Food and Drug Administration Pregnancy and Lactation Labeling Rule.

Autor: Patel A; Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada., Sushko K; Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada. Electronic address: sushkokj@mcmaster.ca., Mazer-Amirshahi M; Department of Emergency Medicine, MedStar Washington Hospital Center, Washington, DC., Pfuma Fletcher E; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD., Fusch G; Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada., Chan O; Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada., Aghayi A; Faculty of Science, McGill University, Montreal, Quebec, Canada., Chan AKC; Division of Hematology/Oncology, Department of Pediatrics, McMaster Children's Hospital, Hamilton, Ontario, Canada., Lacaze-Masmonteil T; Division of Neonatology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada., Van Den Anker J; Division of Clinical Pharmacology, Department of Pediatrics, Children's National Health System, Washington, DC; Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel, Switzerland., Samiee-Zafarghandy S; Division of Neonatology, Department of Pediatrics, McMaster Children's Hospital, Hamilton, Ontario, Canada.
Jazyk: angličtina
Zdroj: The Journal of pediatrics [J Pediatr] 2023 Aug; Vol. 259, pp. 113342. Date of Electronic Publication: 2023 Feb 18.
DOI: 10.1016/j.jpeds.2023.01.016
Abstrakt: Objective: To explore the extent and type of pregnancy and lactation data of newly approved prescription drugs and assess whether the presented recommendations are data-driven, as required by the US Food and Drug Administration Pregnancy and Lactation Labeling Rule implemented in 2015.
Study Design: In this descriptive analysis, we reviewed pregnancy and lactation data of all new molecular entities approved between 2001 and 2020 in their most updated labeling. Information was collected regarding the pregnancy and lactation risk statements, the source of pregnancy and lactation data, and the design and methods of pregnancy and lactation studies in the labeling.
Results: Of the 422 new molecular entities, the key advisory statement for use of 133 (32%) drugs in pregnancy and 194 (46%) drugs in lactation were classified as "against use." Less than 2% of all drugs had a key advisory statement that supported their use during pregnancy or lactation. The sources of data regarding use in pregnancy were studies in human and animals in 46 (11%) and 348 (82%) drugs, respectively. For use during lactation, data included studies in human and animals in 23 (5%) and 251 (59%) drugs, respectively. The key advisory recommendation was consistent with the available human information in 4 (8%) drugs in pregnancy and 3 (13%) drugs in lactation. Prescription drug labeling contains limited data to support informed decision-making for the use of prescription drugs during pregnancy/lactation. Close collaboration among stakeholders is required to enhance the availability of data in this population.
(Copyright © 2023 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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