| Today's Challenges in Pharmacovigilance: What can we Learn from Epoetins? | |
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MedLine Citation:
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PMID: 21417500 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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Highly publicized safety issues of medicinal products in recent years and the accompanying political pressure have forced both the US FDA and the European Medicines Agency (EMA) to implement stronger regulations concerning pharmacovigilance. These legislative changes demand more proactive risk management strategies of both pharmaceutical companies and regulators to characterize and minimize known and potential safety concerns. Concurrently, comprehensive surveillance systems are implemented, intended to identify and confirm adverse drug reactions, including the creation of large pharmacovigilance databases and the cooperation with epidemiological centres. Although the ambitions are high, not much is known about how effective all these measures are, or will be. In this review we analyse how the pharmacovigilance community has acted upon two adverse events associated with the use of erythropoiesis-stimulating agents: the sudden increase in pure red cell aplasia and the possible risk of tumour progression associated with these products. These incidents provide important insight for improving pharmacovigilance, but also pose new challenges for regulatory decision making. |
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Authors:
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Hans C Ebbers; Aukje K Mantel-Teeuwisse; Ellen H M Moors; Huub Schellekens; Hubert G Leufkens |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Drug safety : an international journal of medical toxicology and drug experience Volume: 34 ISSN: 0114-5916 ISO Abbreviation: Drug Saf Publication Date: 2011 Apr |
Date Detail:
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Created Date: 2011-03-22 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9002928 Medline TA: Drug Saf Country: New Zealand |
Other Details:
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Languages: eng Pagination: 273-87 Citation Subset: IM |
Affiliation:
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Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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