Safety information on QT-interval prolongation: comparison of European Union and United States drug labeling

TY - JOUR

T1 - Safety information on QT-interval prolongation

T2 - comparison of European Union and United States drug labeling

AU - Warnier, Miriam J

AU - Holtkamp, Frank A

AU - Rutten, Frans H

AU - Hoes, Arno W

AU - de Boer, Anthonius

AU - Mol, Peter G M

AU - De Bruin, Marie L

N1 - Copyright © 2014 Elsevier Ltd. All rights reserved.

PY - 2014/9

Y1 - 2014/9

N2 - Prolongation of the QT interval can predispose to fatal ventricular arrhythmias. Differences in QT-labeling language can result in miscommunication and suboptimal risk mitigation. We systematically compared the phraseology used to communicate on QT-prolonging properties of 144 drugs newly approved (1st January 2006 to 1st June 2012) in the European Union (EU) and the United States (US), of which 66 mentioned the term 'QT' (two EU only, 28 US only, 36 both). The agreement between authorities about the message on QT prolongation (does not prolong, unclear, possibly prolongs, prolongs) was moderate (kappa 0.434). However, the agreement in expected clinical decisions based on the product labels was much higher (kappa 0.673). The US drug label tends to be more explicit, especially when it considers absence of QT effects.

AB - Prolongation of the QT interval can predispose to fatal ventricular arrhythmias. Differences in QT-labeling language can result in miscommunication and suboptimal risk mitigation. We systematically compared the phraseology used to communicate on QT-prolonging properties of 144 drugs newly approved (1st January 2006 to 1st June 2012) in the European Union (EU) and the United States (US), of which 66 mentioned the term 'QT' (two EU only, 28 US only, 36 both). The agreement between authorities about the message on QT prolongation (does not prolong, unclear, possibly prolongs, prolongs) was moderate (kappa 0.434). However, the agreement in expected clinical decisions based on the product labels was much higher (kappa 0.673). The US drug label tends to be more explicit, especially when it considers absence of QT effects.

KW - Drug Labeling

KW - Drug-Related Side Effects and Adverse Reactions

KW - European Union

KW - Humans

KW - Long QT Syndrome

KW - United States

KW - Comparative Study

KW - Journal Article

U2 - 10.1016/j.drudis.2014.06.017

DO - 10.1016/j.drudis.2014.06.017

M3 - Journal article

C2 - 24973646

SN - 1359-6446

VL - 19

SP - 1294

EP - 1297

JO - Drug Discovery Today: BIOSILICO

JF - Drug Discovery Today: BIOSILICO

IS - 9

ER -