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

Research output: Contribution to journalJournal articleResearchpeer-review

  • Miriam J Warnier
  • Frank A Holtkamp
  • Frans H Rutten
  • Arno W Hoes
  • Anthonius de Boer
  • Peter G M Mol
  • Marie L De Bruin

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.

Original languageEnglish
JournalDrug Discovery Today
Volume19
Issue number9
Pages (from-to)1294-7
Number of pages4
ISSN1359-6446
DOIs
Publication statusPublished - Sep 2014
Externally publishedYes

    Research areas

  • Drug Labeling, Drug-Related Side Effects and Adverse Reactions, European Union, Humans, Long QT Syndrome, United States, Comparative Study, Journal Article

ID: 164618694