Premium
Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary
Author(s) -
Wang J,
Johnson T,
Sahin L,
Tassinari MS,
Anderson PO,
Baker TE,
BucciRechtweg C,
Burckart GJ,
Chambers CD,
Hale TW,
JohnsonLyles D,
Nelson RM,
Nguyen C,
PicaBranco D,
Ren Z,
Sachs H,
Sauberan J,
Zajicek A,
Ito S,
Yao LP
Publication year - 2017
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.676
Subject(s) - lactation , food and drug administration , medicine , breastfeeding , environmental health , pregnancy , pediatrics , biology , genetics
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.