Affiliations: Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands | Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands | Medicines Evaluation Board (CBG-MEB), Utrecht, The Netherlands | Department of Clinical Pharmacology, University Medical Center Groningen, Groningen, The Netherlands
Note: [] Address for correspondence: Marie L. De Bruin, PharmD, PhD, Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, PO-box 80082, 3508 TB, Utrecht, The Netherlands. Tel.: +31 30 253 7324; Fax: +31 30 253 9166; E-mail: [email protected]
Abstract: 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.
Keywords: Cardiovascular agents/adverse effects, drug approval, torsades de pointes/chemically induced, drug labeling/legislation & jurisprudence, communication
