Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary. Issue 6 (June 2017)

• Record Type: Journal Article
• Authors: Wang, J; Johnson, T; Sahin, L; Tassinari, MS; Anderson, PO; Baker, TE; Bucci‐Rechtweg, C; Burckart, GJ; Chambers, CD; Hale, TW; Johnson‐Lyles, D; Nelson, RM; Nguyen, C; Pica‐Branco, D; Ren, Z; Sachs, H; Sauberan, J; Zajicek, A; Ito, S; Yao, LP
• Is Part Of: Clinical pharmacology & therapeutics. Volume 101:Issue 6(2017)
• Page Start: 736
• Page End: 744
• Publication Date: 2017-06
• Subjects: Pharmacology -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1002/cpt.676
• Languages: English
• ISSNs: 0009-9236

Abstract

Abstract : This report serves as a summary of a 2‐day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential risks to breastfed infants with maternal use of medications during lactation. Discussions included the review of current approaches to collect data on medications used during lactation, and the considerations for future approaches to design and guide clinical lactation studies. This workshop is part of continuing efforts to raise the awareness of the public for women who choose to breastfeed their infants.