Skin cancer signal associated with phosphodiesterase inhibitors: gaining insight through the FDA pharmacovigilance database

Abstract

ABSTRACT Background Panoramic views of post-marketing safety profiles, such as cancer signal, of phosphodiesterase 5A (PDE5A) inhibitors have yet to be fully evaluated. Research design and methods Data from the FDA Adverse Event Reporting System (FAERS) concerning the timeframe between January 1st, 2004 to 30 June 2022 was analyzed through a disproportionality study to understand the association between sildenafil, tadalafil, and vardenafil and cancer. This association was identified using the Reporting odds ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) approaches. Results Sildenafil associated ROR values and IC025 ranged from 9.19 (95% CI 7.72–10.94, IC025 2.77) for metastatic malignant melanoma to 132.23 (95% CI 95.49–183.11, IC025 4.69) for malignant melanoma stage II. Tadalafil associated ROR and IC025 ranged from 6.79 (95% CI 5.41–8.54, IC025 2.27) for metastatic malignant melanoma to 180.17 (95% CI 130.11–249.50, IC025 4.89) for malignant melanoma stage II. Vardenafil associated ROR and IC025 ranged from 23.38 (95% CI 15.20–35.96, IC025 2.63) for metastatic malignant melanoma to 245.77 (95% CI 154.42–391.16, IC025 2.10) for malignant melanoma stage III. Conclusions This study supports the association between sildenafil, tadalafil, and vardenafil with skin cancer signal in erectile dysfunction (ED) patients.