004 Post Finasteride Syndrome: Is dutasteride unfairly accused?

Abstract

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. 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.