The Contribution of National Spontaneous Reporting Systems to Detect Signals of Torsadogenicity: Issues Emerging from the ARITMO Project

作者: Emanuel Raschi , Elisabetta Poluzzi , Francesco Salvo , Ariola Koci , Marc Suling

DOI: 10.1007/S40264-015-0353-1

关键词: Spontaneous reportingPharmacology toxicologyRare eventsData scienceMedicine

摘要: Introduction Spontaneous reporting systems (SRSs) are pivotal for signal detection, especially rare events with a high drug-attributable component, such as torsade de pointes (TdP). Use of different national SRSs is rarely attempted because inherent difficulties, but should be considered on the assumption that diluted in international databases.

参考文章(32)
Norman Stockbridge, Joel Morganroth, Rashmi R. Shah, Christine Garnett, Dealing with Global Safety Issues Drug Safety. ,vol. 36, pp. 167- 182 ,(2013) , 10.1007/S40264-013-0016-Z
Andrew Bate, Antoine Pariente, Manfred Hauben, Bernard Bégaud, Quantitative Signal Detection and Analysis in Pharmacovigilance Mann's Pharmacovigilance. pp. 331- 354 ,(2014) , 10.1002/9781118820186.CH20
Céline Caillet, Laurence Chauvelot-Moachon, Jean-Louis Montastruc, Haleh Bagheri, , Safety profile of enantiomers vs. racemic mixtures: it's the same? British Journal of Clinical Pharmacology. ,vol. 74, pp. 886- 889 ,(2012) , 10.1111/J.1365-2125.2012.04262.X
Ismaïl Ahmed, Frantz Thiessard, Ghada Miremont-Salamé, Françoise Haramburu, Carmen Kreft-Jais, Bernard Bégaud, Pascale Tubert-Bitter, Early detection of pharmacovigilance signals with automated methods based on false discovery rates: a comparative study. Drug Safety. ,vol. 35, pp. 495- 506 ,(2012) , 10.2165/11597180-000000000-00000
Elisabetta Poluzzi, Emanuel Raschi, Ariola Koci, Ugo Moretti, Edoardo Spina, Elijah R. Behr, Miriam Sturkenboom, Fabrizio De Ponti, Antipsychotics and torsadogenic risk: signals emerging from the US FDA Adverse Event Reporting System database. Drug Safety. ,vol. 36, pp. 467- 479 ,(2013) , 10.1007/S40264-013-0032-Z
Hsin-wei Wang, Alan M. Hochberg, Ronald K. Pearson, Manfred Hauben, An Experimental Investigation of Masking in the US FDA Adverse Event Reporting System Database Drug Safety. ,vol. 33, pp. 1117- 1133 ,(2010) , 10.2165/11584390-000000000-00000
Martin Huemer, Leif-Hendrik Boldt, Alexander Wutzler, Abdul Parwani, Sascha Rolf, Daniela Blaschke, Wilhelm Haverkamp, Polymorphic ventricular tachycardia in a patient with herpes encephalitis Journal of Clinical Neuroscience. ,vol. 19, pp. 483- 484 ,(2012) , 10.1016/J.JOCN.2011.04.033
Réginald Hulhoven, Dominique Rosillon, Michel Letiexhe, Marie-Anne Meeus, Agnès Daoust, Armel Stockis, Levocetirizine does not prolong the QT/QTc interval in healthy subjects: results from a thorough QT study European Journal of Clinical Pharmacology. ,vol. 63, pp. 1011- 1017 ,(2007) , 10.1007/S00228-007-0366-5
Gianmario Candore, Kristina Juhlin, Katrin Manlik, Bharat Thakrar, Naashika Quarcoo, Suzie Seabroke, Antoni Wisniewski, Jim Slattery, Comparison of Statistical Signal Detection Methods Within and Across Spontaneous Reporting Databases Drug Safety. ,vol. 38, pp. 577- 587 ,(2015) , 10.1007/S40264-015-0289-5