Continued misuse of orphan drug legislation: a life-threatening risk for mexiletine

Author:

Postema Pieter G1,Schwartz Peter J2,Arbelo Elena3,Bannenberg Wilbert J4,Behr Elijah R5,Belhassen Bernard6,Brugada Josep7,Brugada Pedro8,John Camm A9,Casado-Arroyo Ruben10,‘t Hoen Ellen11,Hollak Carla E M12,Kääb Stefan13,Lambiase Pier D14,Leenhardt Antoine15,Priori Silvia G16,Probst Vincent17,Stunnenberg Bas C18,Tfelt-Hansen Jacob19,Van Engelen Baziel G M18,Veltmann Christian20,Viskin Sami21,Wilde Arthur A M22

Affiliation:

1. Department of Cardiology, Heart Center, Amsterdam University Medical Centers, Academic Medical Center, PO-Box 22700, 1100DE, Amsterdam, The Netherlands, Member of the European Reference Network (ERN) GUARD-Heart

2. Instituto Auxologico Italiano, IRCCS, Center for Cardiac Arrhythmias of Genetic Origin, Milan, Italy. Member of the European Reference Network (ERN) GUARD-Heart

3. Arrhythmia Section, Cardiology Department, Hospital Clínic, Universitat de Barcelona and Institut d’Investigació August Pi i Sunyer (IDIBAPS), Barcelona, Spain, and Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain

4. Pharmaceutical Accountability Foundation, The Netherlands

5. Cardiology Clinical Academic Group, Institute of Molecular and Clinical Sciences, St. George’s, University of London, St. George’s University Hospitals NHS Foundation Trust, London, UK. Member of the European Reference Network (ERN) GUARD-Heart

6. Heart Institute, Hadassah University Hospital, Jerusalem, and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel

7. Cardiology Department, Hospital Clinic, University of Barcelona, Barcelona, Spain

8. Cardiovascular Division, Free University of Brussels, Brussels, Belgium

9. Cardiology Clinical Academic Group, Molecular & Clinical Sciences Institute, St, George’s University of London, London, UK

10. Department of Cardiology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium

11. Medicines Law & Policy, Amsterdam, The Netherlands, and Global Health Unit, University Medical Centre Groningen, The Netherlands

12. Department of Endocrinology and Metabolism, Amsterdam University Medical Centers, Amsterdam, The Netherlands

13. Department of Medicine I, University Hospital Munich, Campus Großhadern, Ludwig-Maximilians University Munich (LMU), Munich, Germany, and DZHK (German Centre for Cardiovascular Research), Partner Site Munich, Munich Heart Alliance (MHA), Munich, Germany

14. Electrophysiology Department, Barts Heart Centre, Barts Health NHS trust, London, UK. Member of the European Reference Network (ERN) GUARD-Heart

15. Unité de Rythmologie, Centre de Référence Maladies Cardiaques Héréditaires, Service de Cardiologie, Université de Paris, AP-HP Hôpital Bichat, Paris, France. Member of the European Reference Network (ERN) GUARD-Heart

16. Department of Molecular Medicine University of Pavia, Cardiology & Molecular Cardiology, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy. Member of the European Reference Network (ERN) GUARD-Heart

17. L’institut du thorax, service de cardiologie du CHU de Nantes, Nantes, France. Member of the European Reference Network (ERN) GUARD-Heart

18. Department of Neurology, Donders Institute for Brain Cognition and Behaviour, Radboud University Medical Center, Nijmegen, The Netherlands

19. Department of Cardiology, Heart Centre, Copenhagen University Hospital, Rigshospitalet, and Department of Forensic Medicine, Faculty of Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Member of the European Reference Network (ERN) GUARD-Heart

20. Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany

21. Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel

22. Department of Cardiology, Heart Center, Amsterdam University Medical Centers, Amsterdam, The Netherlands. Member of the European Reference Network (ERN) GUARD-Heart

Publisher

Oxford University Press (OUP)

Subject

Cardiology and Cardiovascular Medicine

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