Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary

Clinical Pharmacology and Therapeutics
J WangL P Yao

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.

References

Mar 15, 1982·Toxicology and Applied Pharmacology·R L BronaughA L Giles
Jul 13, 2000·The New England Journal of Medicine·S Ito
Apr 23, 2003·Advanced Drug Delivery Reviews·James L McManaman, Margaret C Neville
May 7, 2008·Archives of General Psychiatry·Michael S KramerUNKNOWN Promotion of Breastfeeding Intervention Trial (PROBIT) Study Group
Aug 12, 2008·Clinics in Dermatology·Elka Touitou, Biana Godin
Jul 7, 2010·Pediatrics·Lori Feldman-WinterRuth A Lawrence
Apr 26, 2011·American Journal of Obstetrics and Gynecology·Allen A MitchellUNKNOWN National Birth Defects Prevention Study
Mar 1, 2012·Pediatrics·UNKNOWN Section on Breastfeeding
Nov 28, 2012·Pediatric Clinics of North America·Hilary RoweThomas W Hale
Feb 13, 2013·CMAJ : Canadian Medical Association Journal = Journal De L'Association Medicale Canadienne·Meghan B AzadUNKNOWN CHILD Study Investigators
Aug 28, 2013·Pediatrics·Hari Cheryl Sachs, UNKNOWN Committee On Drugs
Jun 10, 2014·American Journal of Obstetrics and Gynecology·Maryann Mazer-AmirshahiJohannes N van den Anker
Aug 12, 2014·Gastroenterology Clinics of North America·Sara Horst, Sunanda Kane
Aug 13, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Pernille WarrerEbba Holme Hansen
Nov 16, 2014·Advances in Nutrition·Foteini Hassiotou, Peter E Hartmann
Dec 3, 2014·Child and Adolescent Psychiatric Clinics of North America·Hilary RoweThomas W Hale
Jan 4, 2015·The Journal of Pediatrics·Omotomilola M AjetunmobiUNKNOWN Glasgow Centre for Population Health Breastfeeding Project Steering Group
Jan 15, 2015·Journal of Human Lactation : Official Journal of International Lactation Consultant Association·Teresa E BakerThomas W Hale
Apr 4, 2015·Breastfeeding Medicine : the Official Journal of the Academy of Breastfeeding Medicine·Sarah Reece-Stremtan, Kathleen A Marinelli
Jun 2, 2015·JAMA Pediatrics·Efrat L Amitay, Lital Keinan-Boker
Jul 2, 2015·Journal of Crohn's & Colitis·Oriana M DamasMaria T Abreu
Oct 13, 2015·Clinical Obstetrics and Gynecology·Edward R Newton, Thomas W Hale
Nov 14, 2015·Breastfeeding Medicine : the Official Journal of the Academy of Breastfeeding Medicine·Sofia ColaceciRosaria Alvaro
Feb 13, 2016·Lancet·Cesar G VictoraUNKNOWN Lancet Breastfeeding Series Group
Apr 10, 2016·Clinical Pharmacology and Therapeutics·Philip O Anderson, Jason B Sauberan
Apr 26, 2016·Journal of Women's Health·Natasha K Sriraman, Ann Kellams
Dec 28, 2016·Journal of Human Lactation : Official Journal of International Lactation Consultant Association·Laurence Spiesser-RobeletRémi Gagnayre

❮ Previous
Next ❯

Citations

Jul 28, 2017·Breastfeeding Medicine : the Official Journal of the Academy of Breastfeeding Medicine·Philip O Anderson
Sep 25, 2018·Journal of Clinical Pharmacology·Shinya Ito
Feb 8, 2018·Pharmaceutical Research·Philip O Anderson
Mar 20, 2019·Current Pharmaceutical Design·Shinya Ito
Mar 22, 2019·Current Pharmaceutical Design·Domenico VentrellaPieter Annaert
Nov 14, 2019·Neurology. Neuroimmunology and Neuroinflammation·Kristen M KryskoRiley Bove
Jan 25, 2020·Therapeutic Drug Monitoring·Philip D Walson
Sep 26, 2019·Frontiers in Pharmacology·Maria Luisa ImazRocio Martin-Santos
Aug 9, 2018·Australian Journal of Primary Health·Amelia StephensLaura Deckx
Aug 9, 2019·Journal of Medical Internet Research·Bita RezaallahBritt-Isabelle Berg
Jul 14, 2020·Therapeutic Advances in Neurological Disorders·Kristen M KryskoKerstin Hellwig
Feb 3, 2021·Biomedicine & Pharmacotherapy = Biomédecine & Pharmacothérapie·Nina NauwelaertsPieter Annaert
Jun 12, 2020·International Journal of Medical Informatics·José María Paricio-TalayeroLeonardo Landa-Rivera
Apr 6, 2021·Current Treatment Options in Neurology·Kristen M KryskoKerstin Hellwig

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

World Review of Nutrition and Dietetics
A Kirksey, S M Groziak
The New England Journal of Medicine
B Lindmark
Australian Family Physician
M Moore
Journal of the Royal Society of Health
D Smith
© 2022 Meta ULC. All rights reserved