title: Adverse reactions to radiopharmaceuticals in France: analysis of the national pharmacovigilance database.
abstract: BACKGROUND
  Radiopharmaceuticals are regarded as safe by the nuclear medicine community, but up to now, no survey has been conducted with from the perspective of pharmacovigilance.
  
  
  OBJECTIVE
  To describe the adverse reactions to radiopharmaceuticals (ARRPs) reported to the French Pharmacovigilance Database (FPVD).
  
  
  METHODS
  We selected and described all reports encompassing at least one radiopharmaceutical in the FPVD. The annual incidence of reported ARRPs used in diagnosis was also estimated.
  
  
  RESULTS
  From 1989 to 2013, 304 reports of ARRPs were identified (43.0% serious, 12 deaths) in 54.6% women and 45.4% men; the median age was 58 years. Five therapeutic radiopharmaceuticals ((131)I-sodium iodide, (131)I-lipiodol, (89)Sr-chloride, (153)Sm-lexidronam, and (90)Y-ibritumomab-tiuxetan) were involved in 48 reports (97 adverse reactions: 86.6% serious, 9 deaths). Pulmonary disorders represented 44.3% of ARRPs used for therapy, mainly related to (131)I-lipiodol. There were 34 diagnostic radiopharmaceuticals involved in 256 reports (451 adverse reactions: 38.1% serious, 3 deaths); 8 diagnostic products ((99m)Tc-oxidronate, (18)F-fluorodeoxyglucose, (99m)Tc-tin pyrophosphate, (99m)Tc-tetrofosmin, (99m)Tc-dimercaptosuccinic acid, (201)Tl-chloride, (99m)Tc-sestamibi, and (111)In-pentetate) accounted for two-thirds of ARRPs. The most frequent adverse reactions were skin (34.4%), general (18.2%), nervous (9.0%), and gastrointestinal disorders (7.0%). There were 25 cases of altered images and 10 medication errors. The annual incidence of reported adverse reactions ranged from 1.2 × 10(-5) to 3.4 × 10(-5) diagnostic administrations.
  
  
  CONCLUSIONS
  Reported ARRPs occurred rarely and were more serious in the therapeutic than in the diagnostic field. The notification of ARRPs was able to provide new guidance for safe use, as was the case for (131)I-lipiodol. Therefore, it is important to report ARRPs to a pharmacovigilance system.
authors.affiliation: Service de Pharmacologie, Toxicologie et Pharmacovigilance, CHU de Limoges, Limoges, France Faculté de Médecine, Université de Limoges, Limoges, France marie-laure.laroche@chu-limoges.fr.
authors.forename: Marie-Laure
authors.initials: ML
authors.lastname: Laroche
authors.affiliation: Service de Pharmacologie, Toxicologie et Pharmacovigilance, CHU de Limoges, Limoges, France Service de Médecine Nucléaire, CHU de Limoges, Limoges, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Quelven
authors.affiliation: Service de Médecine Nucléaire, CHU de Bordeaux, Bordeaux, France INCIA, UMR 5287, Université de Bordeaux, Talence, France CNRS, INCIA, UMR 5287, Talence, France.
authors.forename: Joachim
authors.initials: J
authors.lastname: Mazère
authors.affiliation: Service de Pharmacologie, Toxicologie et Pharmacovigilance, CHU de Limoges, Limoges, France Faculté de Médecine, Université de Limoges, Limoges, France.
authors.forename: Louis
authors.initials: L
authors.lastname: Merle
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000209:etiology; D005260:Female; D005602:France; D006801:Humans; D015994:Incidence; D008297:Male; D008508:Medication Errors / Q000706:statistics & numerical data; D060735:Pharmacovigilance; D019275:Radiopharmaceuticals / Q000009:adverse effects*
chemical_list: D019275:Radiopharmaceuticals
keywords: France; adverse reactions; inefficacy; medication error; pharmacovigilance; radiopharmaceuticals