title: 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 In 5 out of 10 cases, dronedarone was withdrawn and the patient recovered.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.
authors.affiliation: 1Pharmacology, Therapeutics and Toxicology Department, Universitat Autònoma de Barcelona , E-08193 Bellaterra (Cerdanyola del Vallès), Barcelona , Spain mtr@icf.uab.cat.
authors.forename: Mónica
authors.initials: M
authors.lastname: Tarapués
authors.forename: Gloria
authors.initials: G
authors.lastname: Cereza
authors.forename: Albert
authors.initials: A
authors.lastname: Figueras
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000638:Amiodarone / Q000009:adverse effects / Q000031:analogs & derivatives*; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects*; D016208:Databases, Factual; D000077764:Dronedarone; D006801:Humans; D060735:Pharmacovigilance; D051437:Renal Insufficiency / Q000139:chemically induced* / Q000453:epidemiology; D013030:Spain / Q000453:epidemiology; D013997:Time Factors
chemical_list: D000889:Anti-Arrhythmia Agents; D000077764:Dronedarone; D000638:Amiodarone
keywords: atrial fibrillation; dronedarone; pharmacovigilance; renal failure