title: Statin-associated gynecomastia: evidence coming from the Italian spontaneous ADR reporting database and literature.
abstract: OBJECTIVE
  The aim of this study was to add to the body of evidence on statin-induced gynecomastia based on data retrieved from the Italian spontaneous adverse drug reaction (ADR) reporting database.
  
  
  METHODS
  Spontaneous ADR reports collected in the Italian database up to 31 December 2010 were assessed on a case-by-case basis in a search for evidence of a possible causal association between statins and gynecomastia. Cases of gynecomastia or possible gynecomastia, according to the Medical Dictionary of Regulatory Activities (MedDRA) classification, associated with statin use were retrieved from the database. The findings were compared with the available literature in PubMed.
  
  
  RESULTS
  The database contained 90,448 ADR reports on 21 December 2010. At least one statin was listed as the suspected drug in 2,862 reports, of which 1,334 concerned a male patient. Among these reports, we identified eight cases with the preferred term “gynecomastia” with a statin as suspected drug: four reports of rosuvastatin and four of atorvastatin. One additional report of an unspecified “breast disorder” in a male patient attributed to fluvastatin was identified and included as a possible case. Four case-reports of statin-induced gynecomastia published between 2006 and 2010 were retrieved from PubMed.
  
  
  CONCLUSIONS
  Our findings suggest an association between gynecomastia and statins as a drug class, and the occurrence of this ADR would appear to be more likely with active substances that show an higher potency in inhibiting HMG-CoA reductase enzyme. To date, the safety information provided on the labels of different statin-containing medicines is not standardized. Harmonization of this information would be helpful for both healthcare practitioners and patients.
authors.affiliation: Department of Pharmacology, University of Bologna, Via Irnerio 48, Bologna, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Roberto
authors.forename: Chiara
authors.initials: C
authors.lastname: Biagi
authors.forename: Nicola
authors.initials: N
authors.lastname: Montanaro
authors.forename: Ariola
authors.initials: A
authors.lastname: Koci
authors.forename: Ugo
authors.initials: U
authors.lastname: Moretti
authors.forename: Domenico
authors.initials: D
authors.lastname: Motola
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D016208:Databases, Factual; D005260:Female; D006177:Gynecomastia / Q000139:chemically induced*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D007558:Italy; D008297:Male; D008875:Middle Aged
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors