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Why are there deadly drugs?

Some drugs eventually have to be removed from the market because of a negative benefit-to-harm ratio, including an excess of mortality. Drug safety is the result of multiple factors, commencing with how clinical trials are designed, the information generated by and/or hidden through these trials, tr...

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Detalles Bibliográficos
Autor principal: Lexchin, Joel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4318445/
https://www.ncbi.nlm.nih.gov/pubmed/25656293
http://dx.doi.org/10.1186/s12916-015-0270-2
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author Lexchin, Joel
author_facet Lexchin, Joel
author_sort Lexchin, Joel
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description Some drugs eventually have to be removed from the market because of a negative benefit-to-harm ratio, including an excess of mortality. Drug safety is the result of multiple factors, commencing with how clinical trials are designed, the information generated by and/or hidden through these trials, trial analysis by drug regulatory authorities (DRAs) and the amount of information that DRAs choose to release, the amount of published information regarding drug safety, the effectiveness of postmarket surveillance systems in recognizing and reporting adverse drug reactions, and the structure of DRAs such as the United States Food and Drug Administration and its equivalent in other countries. This commentary will look at each of these issues in order to highlight the problems in the current approach to drug safety and finally indicate how some of these deficiencies should be addressed. Please see related article: http://dx.doi.org/10.1186/s12916-014-0262-7
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spelling pubmed-43184452015-02-06 Why are there deadly drugs? Lexchin, Joel BMC Med Commentary Some drugs eventually have to be removed from the market because of a negative benefit-to-harm ratio, including an excess of mortality. Drug safety is the result of multiple factors, commencing with how clinical trials are designed, the information generated by and/or hidden through these trials, trial analysis by drug regulatory authorities (DRAs) and the amount of information that DRAs choose to release, the amount of published information regarding drug safety, the effectiveness of postmarket surveillance systems in recognizing and reporting adverse drug reactions, and the structure of DRAs such as the United States Food and Drug Administration and its equivalent in other countries. This commentary will look at each of these issues in order to highlight the problems in the current approach to drug safety and finally indicate how some of these deficiencies should be addressed. Please see related article: http://dx.doi.org/10.1186/s12916-014-0262-7 BioMed Central 2015-02-05 /pmc/articles/PMC4318445/ /pubmed/25656293 http://dx.doi.org/10.1186/s12916-015-0270-2 Text en © Lexchin; licensee BioMed Central. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Commentary
Lexchin, Joel
Why are there deadly drugs?
title Why are there deadly drugs?
title_full Why are there deadly drugs?
title_fullStr Why are there deadly drugs?
title_full_unstemmed Why are there deadly drugs?
title_short Why are there deadly drugs?
title_sort why are there deadly drugs?
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4318445/
https://www.ncbi.nlm.nih.gov/pubmed/25656293
http://dx.doi.org/10.1186/s12916-015-0270-2
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