Beyond the black box: drug- and device-associated hypersensitivity events

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Beyond the black box: drug- and device-associated hypersensitivity events

BACKGROUND Drug- and device-associated hypersensitivity reactions are serious toxicities that can result in respiratory failure or acute cardiac ischemic events, or even severe hypersensitivity syndromes such as Stevens-Johnson syndrome. These toxicities are usually poorly described in the "black box" warnings section of the product labels. METHODS Adverse event reports contained in databases...

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beyond the black box approach to ethics!; comment on “expanded hta: enhancing fairness and legitimacy”

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1. Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia 2. Insaf Respiratory Research Institute, Wiesbaden, Germany 3. Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK 4. School of Medical Sciences, University of Sydney, Sydney, Australia 5. Inhalation Consultancy Limited, Leeds, UK; Faculty of Health and Human Sciences, University of Plymouth, Pl...

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ژورنال

عنوان ژورنال: Drug, Healthcare and Patient Safety

سال: 2010

ISSN: 1179-1365

DOI: 10.2147/dhps.s6548