Risk Assessment of the Top 60 Drugs for Drug-Related Sexual Dysfunction: A Disproportionate Analysis from the Food and Drug Administration Adverse Event Reporting System

The study by Lihua Wu and colleagues analyzed 61,722 cases of drug-related sexual dysfunction (SD) using the FDA adverse event reporting system, identifying a disproportionate number of reports linking the top 60 drugs to SD. Finasteride, dutasteride, and silodosin were found to have the highest risk signals. Males aged 31-45 were particularly at risk, and 34 specific drugs, including finasteride and sertraline, were significant risk factors. The study developed a risk model with a predictive accuracy of 0.791 and highlighted that 24 drugs did not indicate SD risk in their instructions, suggesting incomplete safety information. The findings underscore the need for healthcare providers to monitor and manage drug-related SD to improve patient outcomes, although causality could not be established due to the study's retrospective nature.