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Drug-induced cardiac abnormalities in premature infants and neonates.

Abstract The Cardiac Safety Research Consortium (CSRC) is a transparent, public-private partnership that was established in 2005 as a Critical Path Program and formalized in 2006 under a Memorandum of Understanding between the United States Food and Drug Administration and Duke University. Our continuing goal is to advance paradigms for more efficient regulatory science related to the cardiovascular safety of new therapeutics, both in the United States and globally, particularly where such safety questions add burden to innovative research and development. This White Paper provides a summary of discussions by a cardiovascular committee cosponsored by the CSRC and the US Food and Drug Administration (FDA) that initially met in December 2014, and periodically convened at FDA's White Oak headquarters from March 2015 to September 2016. The committee focused on the lack of information concerning the cardiac effects of medications in the premature infant and neonate population compared with that of the older pediatric and adult populations. Key objectives of this paper are as follows: Provide an overview of human developmental cardiac electrophysiology, as well as the electrophysiology of premature infants and neonates; summarize all published juvenile animal models relevant to drug-induced cardiac toxicity; provide a consolidated source for all reported drug-induced cardiac toxicities by therapeutic area as a resource for neonatologists; present drugs that have a known cardiac effect in an adult population, but no reported toxicity in the premature infant and neonate populations; and summarize what is not currently known about drug-induced cardiac toxicity in premature infants and neonates, and what could be done to address this lack of knowledge. This paper presents the views of the authors and should not be construed to represent the views or policies of the FDA or Health Canada.
PMID
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Authors

Mayor MeshTerms

Infant, Premature

Keywords
Journal Title american heart journal
Publication Year Start




PMID- 29224642
OWN - NLM
STAT- MEDLINE
DCOM- 20171215
LR  - 20171215
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 195
DP  - 2018 Jan
TI  - Drug-induced cardiac abnormalities in premature infants and neonates.
PG  - 14-38
LID - S0002-8703(17)30214-4 [pii]
LID - 10.1016/j.ahj.2017.07.014 [doi]
AB  - The Cardiac Safety Research Consortium (CSRC) is a transparent, public-private
      partnership that was established in 2005 as a Critical Path Program and
      formalized in 2006 under a Memorandum of Understanding between the United States 
      Food and Drug Administration and Duke University. Our continuing goal is to
      advance paradigms for more efficient regulatory science related to the
      cardiovascular safety of new therapeutics, both in the United States and
      globally, particularly where such safety questions add burden to innovative
      research and development. This White Paper provides a summary of discussions by a
      cardiovascular committee cosponsored by the CSRC and the US Food and Drug
      Administration (FDA) that initially met in December 2014, and periodically
      convened at FDA's White Oak headquarters from March 2015 to September 2016. The
      committee focused on the lack of information concerning the cardiac effects of
      medications in the premature infant and neonate population compared with that of 
      the older pediatric and adult populations. Key objectives of this paper are as
      follows: Provide an overview of human developmental cardiac electrophysiology, as
      well as the electrophysiology of premature infants and neonates; summarize all
      published juvenile animal models relevant to drug-induced cardiac toxicity;
      provide a consolidated source for all reported drug-induced cardiac toxicities by
      therapeutic area as a resource for neonatologists; present drugs that have a
      known cardiac effect in an adult population, but no reported toxicity in the
      premature infant and neonate populations; and summarize what is not currently
      known about drug-induced cardiac toxicity in premature infants and neonates, and 
      what could be done to address this lack of knowledge. This paper presents the
      views of the authors and should not be construed to represent the views or
      policies of the FDA or Health Canada.
CI  - Copyright (c) 2017. Published by Elsevier Inc.
FAU - Pesco-Koplowitz, Luana
AU  - Pesco-Koplowitz L
AD  - DUCK FLATS Pharma, Elbridge, NY. Electronic address: [email protected]
FAU - Gintant, Gary
AU  - Gintant G
AD  - AbbVie, North Chicago, IL.
FAU - Ward, Robert
AU  - Ward R
AD  - University of Utah, Salt Lake City, UT.
FAU - Heon, Dominique
AU  - Heon D
AD  - Health Canada, Ottawa, Ontario, Canada.
FAU - Saulnier, Muriel
AU  - Saulnier M
AD  - US Food and Drug Administration, Silver Spring, MD.
FAU - Heilbraun, Jeff
AU  - Heilbraun J
AD  - Bioclinica, Doylestown, PA.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20170731
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
SB  - AIM
SB  - IM
MH  - Animals
MH  - Drug-Related Side Effects and Adverse Reactions/*complications
MH  - Heart Defects, Congenital/*chemically induced
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - *Infant, Premature
EDAT- 2017/12/12 06:00
MHDA- 2017/12/16 06:00
CRDT- 2017/12/12 06:00
PHST- 2017/07/27 00:00 [received]
PHST- 2017/07/27 00:00 [accepted]
PHST- 2017/12/12 06:00 [entrez]
PHST- 2017/12/12 06:00 [pubmed]
PHST- 2017/12/16 06:00 [medline]
AID - S0002-8703(17)30214-4 [pii]
AID - 10.1016/j.ahj.2017.07.014 [doi]
PST - ppublish
SO  - Am Heart J. 2018 Jan;195:14-38. doi: 10.1016/j.ahj.2017.07.014. Epub 2017 Jul 31.