Advertisement

European Journal of Clinical Pharmacology

, Volume 68, Issue 6, pp 1007–1011 | Cite as

Statin-associated gynecomastia: evidence coming from the Italian spontaneous ADR reporting database and literature

  • Giuseppe Roberto
  • Chiara Biagi
  • Nicola Montanaro
  • Ariola Koci
  • Ugo Moretti
  • Domenico Motola
Short Communication

Abstract

Purpose

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.

Keywords

Statins Gynecomastia Adverse drug reaction Spontaneous reporting database 

Notes

Acknowledgments

The study was supported by funds from the Emilia Romagna Region and the University of Bologna.

Competing interest

The authors declare that they have no conflict of interest.

References

  1. 1.
    Braunstein GD (2007) Clinical practice. Gynecomastia. N Engl J Med 357:1229–1237PubMedCrossRefGoogle Scholar
  2. 2.
    Braunstein GD (2010) Epidemiology and pathogenesis of gynecomastia. UpToDate 19.3. Available at: http://www.uptodate.com/contents/epidemiology-and-pathogenesis-of-gynecomastia
  3. 3.
    Devalia HL, Layer GT (2009) Current concepts in gynaecomastia. Surgeon 7:114–119PubMedCrossRefGoogle Scholar
  4. 4.
    Goldman RD (2010) Drug-induced gynecomastia in children and adolescents. Can Fam Physician 56:344–345PubMedGoogle Scholar
  5. 5.
    Rahmani S, Turton P, Shaaban A, Dall B (2011) Overview of gynecomastia in the modern era and the Leeds Gynaecomastia Investigation algorithm. Breast J 17:246–255PubMedCrossRefGoogle Scholar
  6. 6.
    Brown EG, Wood L, Wood S (1999) The medical dictionary for regulatory activities (MedDRA). Drug Saf 20:109–117PubMedCrossRefGoogle Scholar
  7. 7.
    Picolos MK, Zeniou V, Michalis A (2010) Rosuvastatin-induced gynaecomastia. Clin Endocrinol (Oxf) 73:421–422CrossRefGoogle Scholar
  8. 8.
    Aerts J, Karmochkine M, Raguin G (1999) Gynecomastia due to pravastatin. Presse Med 28:787PubMedGoogle Scholar
  9. 9.
    Hammons KB, Edwards RF, Rice WY (2006) Golf-inhibiting gynecomastia associated with atorvastatin therapy. Pharmacotherapy 26:1165–1168PubMedCrossRefGoogle Scholar
  10. 10.
    Oteri A, Catania MA, Travaglini R, Russo A, Giustini SE, Caputi AP, Polimeni G (2008) Gynecomastia possibly induced by rosuvastatin. Pharmacotherapy 28:549–551PubMedCrossRefGoogle Scholar
  11. 11.
    Federal Drug Administration (FDA) (2011) Lescol® (fluvastatin sodium)—prescribing information. FDA, Washington D.C.Google Scholar
  12. 12.
    Compendio Farmaceutico Telematico–Farmadati Italia (2011) Lescol® (fluvastatin sodium)—Riassunto delle Caratteristiche del ProdottoGoogle Scholar
  13. 13.
    Compendio Farmaceutico Telematico–Farmadati Italia (2011) Torvast® (atorvastatin calcium)—Riassunto delle Caratteristiche del ProdottoGoogle Scholar
  14. 14.
    Federal Drug Administration (FDA) (2011) Lipitor® (atorvastatin calcium)—prescribing information. FDA, Washington D.C.Google Scholar
  15. 15.
    van Puijenbroek E, Diemont W, van Grootheest K (2003) Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions. Drug Saf 26:293–301PubMedCrossRefGoogle Scholar
  16. 16.
    Mozzicato P MedDRA: an overview of the medical dictionary for regulatory activities. Pharmaceut Med 23:65–75Google Scholar
  17. 17.
    Fischereder M, Grab C, Anthuber M, Kruger B, Zulke C, Jauch KW, Kramer BK (2002) Gynaecomastia following solid organ transplantation. Transplant Proc 34:2227–2228PubMedCrossRefGoogle Scholar
  18. 18.
    Gruppo di lavoro OsMed (2011) L’uso dei farmaci in Italia. Rapporto nazionale anno 2010. Available at: http://www.agenziafarmaco.gov.it/sites/default/files/rapporto_osmed_2010_0.pdf
  19. 19.
    Uppsala Monitoring Centre (2011) Vigibase online: the World Health Organization’s adverse drug reaction database. Available at: http://www.who-umc.org. Accessed 26 Oct 2011

Copyright information

© Springer-Verlag 2012

Authors and Affiliations

  • Giuseppe Roberto
    • 1
  • Chiara Biagi
    • 1
  • Nicola Montanaro
    • 1
  • Ariola Koci
    • 1
  • Ugo Moretti
    • 2
  • Domenico Motola
    • 1
  1. 1.Department of PharmacologyUniversity of BolognaBolognaItaly
  2. 2.Department of Public Health and Community Medicine, Section of Pharmacology, Faculty of MedicineUniversity of VeronaVeronaItaly

Personalised recommendations