Assessment of the U.S. Food and Drug Administration's risk evaluation and mitigation strategy (REMS) for prasugrel (EFFIENT): A narrative review

Assessment of the U.S. Food and Drug Administration's risk evaluation and mitigation strategy (REMS) for prasugrel (EFFIENT): A narrative review

Background: Prasugrel, first approved in 2009, was subject to a US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) to mitigate the risk of bleeding associated with its use. Methods: We performed a narrative review of FDA documents obtained through a Freedom of Infor...

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Bibliographic Details
Main Authors: Thomas Metkus, Jill Curran, Shanshan Lin, Dima M. Qato, G. Caleb Alexander
Format: Article
Language:English
Published: Elsevier 2024-02-01
Series:American Heart Journal Plus
Subjects:
U.S. Food and Drug Administration
Risk evaluation and mitigation programs
Drug risks
Online Access:http://www.sciencedirect.com/science/article/pii/S2666602224000028

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http://www.sciencedirect.com/science/article/pii/S2666602224000028

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