Dronedarone-associated acute renal failure: evidence coming from the Italian spontaneous ADR reporting database

Authors

  • Chiara Biagi,

    Corresponding author
    1. Pharmacovigilance Regional Centre of Emilia Romagna, Bologna, Italy
    • Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
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  • Mauro Venegoni,

    1. Pharmacovigilance Regional Centre of Lombardy, Milan, Italy
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  • Mauro Melis,

    1. Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
    2. Pharmacovigilance Regional Centre of Emilia Romagna, Bologna, Italy
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  • Elena Buccellato,

    1. Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
    2. Pharmacovigilance Regional Centre of Emilia Romagna, Bologna, Italy
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  • Nicola Montanaro,

    1. Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
    2. Pharmacovigilance Regional Centre of Emilia Romagna, Bologna, Italy
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  • Domenico Motola

    1. Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
    2. Pharmacovigilance Regional Centre of Emilia Romagna, Bologna, Italy
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Correspondence

Dr Chiara Biagi, PharmD, Department of Medical and Surgical Sciences, University of Bologna, Via Irnerio 48, 40126 Bologna, Italy.

Tel.: +39 0519 1781

Fax: +39 0 5124 8862

E-mail: chiara.biagi@unibo.it

Abstract

Aim

To describe cases of acute renal failure (ARF) and of renal failure (RF) from dronedarone retrieved in the general population during post-marketing surveillance through the Italian spontaneous ADR reporting database.

Methods

A case by case analysis was performed. Reports codified with the System Organ Class (SOC) term ‘urinary system disorders’ of the ADR terminology of the World Health Organization associated with dronedarone treatment were selected.

Results

Out of 124 069 ADR reports, in 55 of them dronedarone was listed as the suspected drug. Among these reports, we identified four cases of ARF, two of RF and three cases of increase of blood creatinine submitted by physicians between October 2010 and December 2011. The patient age was from 61 to 84 years and most cases occurred within the first 13 days of initiation of dronedarone therapy (range 6 days – 2 months). Only one patient received a co-suspected drug labelled for causing ARF. In all reports but one, positive dechallenge was reported.

Conclusions

Clinicians should be made aware of the risk of ARF/RF associated with dronedarone and of the need to screen patients appropriately for ARF/RF risk factors before starting dronedarone therapy.

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