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Cardiovascular safety of drugs not intended for cardiovascular use: need for a new conceptual basis for assessment and approval


Borer, Jeffrey S; Pouleur, Hubert; Abadie, Eric; Follath, Ferrenc; Wittes, Janet; Pfeffer, Marc A; Pitt, Bertram; Zannad, Faiez (2007). Cardiovascular safety of drugs not intended for cardiovascular use: need for a new conceptual basis for assessment and approval. European Heart Journal, 28(15):1904-1909.

Abstract

Recently, several drugs for non-cardiovascular diseases have ceased marketing because of cardiovascular risk, highlighting the importance of evaluating the cardiovascular safety of new drugs even if not intended for cardiovascular diseases. Assessing and ensuring acceptable cardiovascular safety of non-cardiovascular drugs is difficult; nonetheless, governmental regulatory agencies are likely to change the requirements for drug safety information. This article explores our recommendations for rethinking current regulatory policies, emphasizing the need for mandatory post-marketing surveillance registries and highlighting the exposures necessary to subserve the need for greater assessment of safety issues

Abstract

Recently, several drugs for non-cardiovascular diseases have ceased marketing because of cardiovascular risk, highlighting the importance of evaluating the cardiovascular safety of new drugs even if not intended for cardiovascular diseases. Assessing and ensuring acceptable cardiovascular safety of non-cardiovascular drugs is difficult; nonetheless, governmental regulatory agencies are likely to change the requirements for drug safety information. This article explores our recommendations for rethinking current regulatory policies, emphasizing the need for mandatory post-marketing surveillance registries and highlighting the exposures necessary to subserve the need for greater assessment of safety issues

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Item Type:Journal Article, refereed, original work
Communities & Collections:National licences > 142-005
Dewey Decimal Classification:570 Life sciences; biology
610 Medicine & health
Language:English
Date:1 August 2007
Deposited On:30 Oct 2018 16:07
Last Modified:24 Sep 2019 23:40
Publisher:Oxford University Press
ISSN:0195-668X
OA Status:Green
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1093/eurheartj/ehm209
Related URLs:https://www.swissbib.ch/Search/Results?lookfor=nationallicenceoxford101093eurheartjehm209 (Library Catalogue)
PubMed ID:17615083

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