Dronedarone and renal impairment: evaluation of Spanish postmarketing reports and review of literature

Abstract

Background: Renal impairment associated with dronedarone use is hardly known. Our aim is to describe the characteristics of spontaneous reports involving renal adverse reactions with use of dronedarone.

Methods: In the Spanish Pharmacovigilance database, reports with renal reactions and dronedarone until May 2014 were retrieved and analyzed. Also, a review of case reports of renal failure and dronedarone was conducted in MEDLINE.

Results: Dronedarone was found as a suspected drug in 192 reports, 10 (5.2%) of these reports described renal reactions. Renal reactions appeared until 3 months after the onset of dronedarone treatment. In 5 out of 10 cases, dronedarone was withdrawn and the patient recovered. The Reporting Odds Ratio was 2.88 [95% CI 1.52 – 5.46; p < 0.05]. Additionally, eight cases were found in the medical literature. In five of them, the patient outcome was described as recovered. One patient had to undergo hemodialysis for the treatment of their renal impairment.

Conclusions: The effect of dronedarone on the renal function is supported by limited information; therefore, the cases from spontaneous reporting system and those from the medical literature could give relevant additional information. Our analysis shows a potential relationship between dronedarone use and renal impairment. Further studies are needed to confirm these findings.

Keywords:

• atrial fibrillation
• dronedarone
• pharmacovigilance
• renal failure

Acknowledgments

We would like to thank the reporting physicians and the Spanish Pharmacovigilance Centers.

Declaration of interest

This work was supported in part by the Departament de Salut de la Generalitat de Catalunya, a government institution of Catalonia. M Tarapués is preparing her doctoral thesis in the Spanish Pharmacovigilance System/Universitat Autònoma de Barcelona. She received a research grant from Secretaria Nacional de Educación Superior, Ciencia y Tecnología del Ecuador (SENESCYT), a public institution. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.