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Details van artikel 6 van 8 gevonden artikelen
| Titel: |
Quality of drug label information on QT interval prolongation |
| Auteur: |
Warnier, Miriam J. Holtkamp, Frank A. Rutten, Frans H. Hoes, Arno W. de Boer, Anthonius Mol, Peter G.M. De Bruin, Marie L. |
| Verschenen in: |
International journal of risk & safety in medicine |
| Paginering: | Jaargang 26 (2014) nr. 2 pagina's 89-98 |
| Jaar: |
2014-06-05 |
| Inhoud: |
BACKGROUND: Information regarding QT-prolongation in the drug label may vary between products. This could lead to suboptimal risk minimization strategies. OBJECTIVE: To systematically assess the variation in the extent and content of information on QT prolongation in the summary of product characteristics (SPC) of recently approved medicinal products. METHODS: Drug labels of products centrally approved in Europe between 2006 and 2012 were screened. Of drugs including the term ‘QT’ in the SPC, the message on QT-prolongation (‘no prolongation’/‘unclear drug-QT association’/‘possibly QT-prolongation’/‘QT-prolongation’) and the advice on cautionary measures pertaining to QT-prolongation in the label were examined, as well as their association. RESULTS: Of the 175 screened products, 44 contained information on QT in the SPC (‘no QT-prolongation’: 23%, ‘unclear drug-QT association’: 43%, ‘possibly QT-prolongation’: 16%, ‘QT-prolongation’: 18%). 62% contained advices to act with caution in patients with additional risk factors for QT-prolongation. Products that more likely to have QT-prolonging properties according to the SPC provided more information on QT-prolongation in the SPC (‘no prolongation’: 10% and for the category ‘QT-prolongation’: 100%). CONCLUSIONS: The extent and content of information on QT-prolongation varies considerably between SPCs, and in almost half of the drugs a clear message on QT-prolongation was lacking in the SPC. |
| Uitgever: |
IOS Press |
| Bronbestand: |
Elektronische Wetenschappelijke Tijdschriften |
Details van artikel 6 van 8 gevonden artikelen
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