004 Post Finasteride Syndrome: is Dutasteride Unfairly Accused?

Abstract

Objectives: Finasteride (FIN), a 5α-reductase inhibitor (5-ARI's), is used to treat benign prostatic hyperplasia and alopecia. Controversial research has suggested that finasteride, can result in persistent sexual and nonsexual side effects known as post-finasteride syndrome (PFS). Because of a shared mechanism of action, dutasteride voluntarily underwent an FDA label change similar to that for FIN. The aim of this study was to evaluate adverse effects associated with dutasteride by examining an FDA Adverse Event Reporting Symptoms (FAERS) database. The aim of this report was to address PFS putatively induced by dutasteride by quantifying and summarizing these FAERS reports, create a demographic of patient reports, assess the cluster of PFS symptoms, and to correlate consistency of the PFS syndrome. Materials and Methods: A FAERS database between 4/1/2011 and 10/29/2014 pertaining to all 5-ARI's received was analyzed. Every reported case was coded according to date received, case type, whether it was reported by a health professional, outcomes, manufacturer, age of patient, country, product used, adverse events, and the suspected role of the reported drug. Results: The FAERS database consisted of 3,295 cases (2,986 male and 305 either female or gender unreported). Of the 2,986 male cases, 31 were with the concomitant use of finasteride and dutasteride. There was only one reported case of dutasteride which caused “back pain.” Sexual dysfunction was reported in 16% of cases with a combination of finasteride and dutasteride. Overall, 41% incidences of PFS symptoms were reported with finasteride alone and none with dutasteride alone. Conclusion: Use of a FAERS database demonstrated that there were no persistent sexual side effects reported over a 3.5 year period associated with the use of dutasteride alone. Although the FAERS has limitations such as self-reported data, our findings suggest that dutasteride is not associated with PFS.