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European Heart Journal Advance Access originally published online on July 5, 2007
European Heart Journal 2007 28(15):1904-1909; doi:10.1093/eurheartj/ehm209
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© The European Society of Cardiology 2007. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

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

Jeffrey S. Borer1,*, Hubert Pouleur2, Eric Abadie3, Ferrenc Follath4, Janet Wittes5, Marc A. Pfeffer6, Bertram Pitt7 and Faiez Zannad8

1 Division of Cardiovascular Pathophysiology, Weill Medical College of Cornell University, 47 East 88th Street, New York, NY 10128-1152, USA
2 Pfizer, Inc., New York, NY, USA
3 AFSSAPS, Paris, France
4 University Hospital, Zurich, Switzerland
5 Statistics Collaborative, Washington DC, USA
6 Brigham and Women's Hospital, Boston, MA, USA
7 University of Michigan, Ann Arbor, MI, USA
8 Hypertension and Preventive Cardiology Division, Department of Cardiovascular disease, Centre d'Investigations Cliniques INSERM-CHU, INSERM U684, Nancy, France

Received 4 December 2006; revised 24 April 2007; accepted 3 May 2007; online publish-ahead-of-print 5 July 2007.

* Corresponding author. Tel: +1 212 746 4646; fax: +1 212 426 4353. E-mail address: canadad45{at}aol.com

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.

Key Words: Cardiovascular diseases • Safety • Drug evaluation


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