Association of 5-Alpha Reductase Inhibitors and Sexual Dysfunction: A RADAR Report
February 2013
in “
Journal of The American Academy of Dermatology
”
5-α reductase inhibitors finasteride dutasteride sexual adverse experiences decreased libido ejaculation disorders erectile dysfunction FDA Adverse Event Reporting System decreased semen volume testicular pain depression anxiety suicidal ideation 5-αRIs Propecia Avodart SAEs libido ejaculation erection FDA AERS semen volume suicidal thoughts
TLDR Using hair loss drugs finasteride and dutasteride may cause sexual side effects.
The document reports a significant association between the use of 5-α reductase inhibitors (5-αRIs), specifically finasteride (F) and dutasteride (D), and sexual adverse experiences (SAEs) such as decreased libido, ejaculation disorders, and erectile dysfunction. The study analyzed data from the FDA Adverse Event Reporting System (AERS) database up to December 2011, finding 431 reports of SAEs associated with F 1 mg, 1089 with F 5 mg, and 387 with D. The mean age of patients experiencing SAEs was 36.5 years for F 1 mg, 64.4 years for F 5 mg, and 66.5 years for D. The proportional reporting ratios (PRRs) and empiric Bayes geometric means (EBGM) indicated a highly significant association between 5-αRI exposure and SAEs. Additionally, reports of decreased semen volume, testicular pain, depression, anxiety, and suicidal ideation were also noted. The study emphasizes the need for further investigation due to the strong safety signals and reports of persistent SAEs even after discontinuation of the medication.