Today’s Challenges in Pharmacovigilance
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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.
KeywordsProgressive Multifocal Leukoencephalopathy Insulin Glargine Allogenic Blood Transfusion Eprex Marketing Authorization Holder
All authors declare no conflicts of interest relevant to the subject matter or materials discussed in the review. This study was performed in the context of the Escher project (T6-202), a project of the Dutch Top Institute Pharma. The Division of Pharmacoepidemiology and Clinical Pharmacology, employing authors Hans C. Ebbers, Aukje K. Mantel-Teeuwisse and Hubert G. Leufkens, has received unrestricted funding for pharmacoepidemiological research from GlaxoSmithKline, the private-public funded Top Institute Pharma (www. tipharma.nl; includes co-funding from universities, government, and industry), the Dutch Medicines Evaluation Board and the Dutch Ministry of Health. H. Schellekens participated in meetings and publications sponsored by Amgen, Johnson & Johnson, Roche, Sandoz and Hospira. Part of his research is directly or indirectly sponsored by Roche and Amgen. E. Moors has no conflicts of interest to declare.
The authors wish to thank Professor Nicole Casadevall for the fruitful discussions and her insights of the events surrounding PRCA. The authors are indebted to the national centres contributing data to the WHO-UMC International Drug Monitoring Programme. The opinions and conclusions, however, are not necessarily those of the various centres or of the WHO.
The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or any other regulatory agency, or one of its committees or working parties.
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