van Vulpen, L., Saccullo, G., Iorio, A. et al. (1 more author) (2017) The current state of adverse event reporting in hemophilia. Expert Review of Hematology, 10 (2). pp. 161-168. ISSN 1747-4086
Abstract
Introduction: Replacement of the missing clotting factor is the mainstay of haemophilia treatment. Whilst historically many haemophilia patients were infected with blood-borne vi-ruses transmitted via plasma-derived products, nowadays the formation of alloantibodies against the missing clotting factor is the main adverse event of treatment. Areas covered: This paper provides an overview of the current national and international adverse event reporting systems, what these surveillance schemes taught us about side effects of the products presently in use, and elaborates on how to adapt these systems to the challeng-es we face with the changing treatment landscape. Expert commentary: Treatment of inherited bleeding disorders was accompanied by severe complications in the past, resulting in major morbidity and mortality. Current products are much safer, but still require monitoring via efficient safety surveillance systems. Adverse events are reported in national and international systems. With many new products entering the market, as well as non-factor replacement therapies, new safety issues may arise. It is im-portant to identify potential adverse events early by making surveillance systems suitable to pick up unknown or unexpected effects, and to recognize and communicate patterns of ad-verse events rapidly.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2017 Taylor & Francis. This is an author produced version of a paper subsequently published in Expert Review of Hematology. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | Bleeding disorders; haemophilia; safety; surveillance, concentrate |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > Department of Infection, Immunity and Cardiovascular Disease The University of Sheffield > Sheffield Teaching Hospitals |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 20 Dec 2016 14:16 |
Last Modified: | 26 Dec 2017 01:38 |
Published Version: | https://doi.org/10.1080/17474086.2017.1272410 |
Status: | Published |
Publisher: | Taylor & Francis |
Refereed: | Yes |
Identification Number: | 10.1080/17474086.2017.1272410 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:109716 |