Assessing dutasteride-associated sexual dysfunction using the U.S. Food and Drug Administration Adverse Event Reporting System.
BACKGROUND: Incidences of sexual dysfunction due to the use of 5 alpha-reductase inhibitors have been suggested. Despite low sexual dysfunction reported in clinical trials, an analysis of the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database revealed a significant disproportionality in the reporting of sexual dysfunction with the use of finasteride. Therefore, it is likely that a similar relationship with dutasteride may exist.
OBJECTIVE: To determine whether dutasteride use leads to a higher risk of sexual dysfunction compared to a baseline risk for all other drugs using the FAERS database.
METHODS: A case by non-case disproportionality approach was used whereby a reporting odds ratio (ROR) with 95% confidence interval (CI) was calculated. Cases of dutasteride-associated sexual dysfunction were compared to a reference risk of sexual dysfunction for all other drugs in the database.
RESULTS: A significant disproportionality in reporting of sexual dysfunction with the use of dutasteride was observed. The disproportionality was present for all age ranges except for 31-45 years where there were few overall reports of adverse events.
LIMITATIONS: Adverse events can be underreported, and selection bias is inherent in the FAERS.
CONCLUSION: Dutasteride use is associated with an increase in reports of sexual dysfunction.
|投稿者||Gupta, A K; Carviel, J; Gupta, M A; Shear, N H|
|ジャーナル名||Journal of the European Academy of Dermatology and Venereology : JEADV|
|組織名||Department of Medicine, University of Toronto School of Medicine, Toronto, ON,;Canada.;Mediprobe Research Inc., London, ON, Canada.;Department of Psychiatry, Schulich School of Medicine and Dentistry, University;of Western Ontario, London, ON, Canada.;Division of Dermatology, Department of Medicine, Sunnybrook Health Sciences;Centre, University of Toronto, Toronto, ON, Canada.|