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Safety and Risk-Benefit Profile of Microbubble Contrast Agents in Echocardiography

… 2007, the US Food and Drug Administration (FDA) imposed a 'black box' warning, new disease state contraindications, and a mandatory …

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Article

The History of Product Label Changes for DEFINITY® in the US

… product labeling for DEFINITY, which included: a 'boxed warning' (indicating that "serious cardiopulmonary reactions, … Main ML, Goldman JH, Grayburn PA, Thinking outside the 'box' - the ultrasound contrast controversy, J Am Coll Cardiol … Product safety compromises patient safety (an unjustified black box warning on ultrasound contrast agents by the Food …

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Article

Update - Clinical Value of Contrast-enhanced Ultrasound

… In October of 2007, the FDA issued a label change ('black box' warnings) and new contraindications for ultrasound … all of the new contraindications and most of the new black box warnings. Additional safety data have since been …

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Article

The 2010 International Society of Hypertension in Blacks Consensus Statement - Is There a Role for Opinion in Guidelines or Consensus Reports? A Review

… using relevant studies, with and without adequate black cohorts, and non-randomized epidemiologic data. There is a definite place for expert opinions in managing black patients with hypertension to curtail the unacceptable, … MD, FACC, FAHA, Chief Science Officer, Association of Black Cardiologists, Director of Clinical Research, Atlanta …

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Article

Susan E Piper

… Susan E Piper King's College London, The James Black Centre, London, UK; Kings College Hospital NHS …

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Author

Improving Care for African-American Heart Failure Patients

… necessarily mean that ACE inhibitors should not be used in black patients. However, with the administration of ACE … therapy.This at least provides some confidence that black patients would benefit from this newer approach when … However, in the subgroup of patients identified as black, there appeared to be a similar response in terms of …

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Article

The US Cardiovascular Arena In Brief—A Round-up of Trends, Statistics, and Clinical Research

… economies in both developed and developing countries. The warning is contained in a report presented to the European … strategies, and medical collaboration. A further warning concerns the encroachment of cardiovascular disease …

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Article

Keith C Ferdinand

… Keith C Ferdinand Chief Science Officer Association of Black Cardiologists, and Clinical Professor of Medicine, …

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Author

Diabetes Drugs and Cardiovascular Event Reduction: A Paradigm Shift

… of evidence, all drugs in the sulfonylurea class carry a 'black box' warning for increased risk of cardiovascular mortality. …

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Article