Drug-induced cardiac abnormalities in premature infants and neonates.

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.

Cardiovascular safety and hemodynamic considerations in oncology drug development - webinar highlights October 10th 2012.

INTRODUCTION: Development of new drugs in oncology may have implications for cardiovascular risk. This report describes some aspects of our growing knowledge in the area of evaluating benefit-risk and may be of direct importance to scientists working in drug discovery and development. AREAS COVERED: This report of webinar highlights entitled "Trends in CardiOncology: the evolution of blood pressure and electrocardiogram (ECG) Markers" covers the current state of pharmacology of selected drugs which induce blood pressure elevation and best practices in employing the measurement of blood pressure elevation and cardiac safety parameters for drug development in oncology. EXPERT OPINION: Oncology drug-induced cardiotoxicity has recently been recognised as an important drug development and clinical issue. The recognition of the risks and opportunities has prompted intensive research into mechanisms of chemotherapy-induced cardiotoxicity and potential prevention strategies. Drug-induced blood pressure elevation has emerged as a key area of interest, both as a marker of efficacy of vascular targeted chemotherapies as well as a target for early intervention strategies. While further research is ongoing, current data strongly suggest that early intervention strategies may provide significant short- and long-term clinical benefits to cancer patients undergoing chemotherapy.