학술논문

Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary
Document Type
article
Source
Clinical Pharmacology & Therapeutics. 101(6)
Subject
Pediatric
Biological Products
Breast Feeding
Congresses as Topic
Consensus Development Conferences as Topic
Drug-Related Side Effects and Adverse Reactions
Female
Humans
Infant
Infant
Newborn
Lactation
Maternal Exposure
Models
Biological
Pregnancy
Risk Assessment
Risk Factors
Pharmacology and Pharmaceutical Sciences
Pharmacology & Pharmacy
Language
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.