Pharmacovigilance Analysis of Melanoma Adverse Events in Men Treated with Sildenafil for Erectile Dysfunction (NEAUA 2022)
We examined confounding by (1) indication, (2) dose, (3) age at report submission, (4) region, (5) stimulated reporting before and after 2014 when there was a sharp increase in awareness about the topic, (6) another phosphodiesterase type-5 inhibitor (tadalafil), (7) drugs prescribed for erectile dysfunction with different mechanisms of action (prostaglandin E1, testosterone, and papaverine), (8) drugs unrelated to erectile dysfunction but prescribed among the same age group (tamsulosin, metoprolol, and metformin), and (9) drugs associated with non-melanoma skin cancer (irbesartan and valsartan). Herein, we found that phosphodiesterase type-5 inhibitors prescribed for erectile dysfunction are associated with cutaneous and ocular melanoma. While there may be confounding by age, region, dose, and stimulated reporting, our results support the need to keep sildenafil on the Food and Drug Administration's list of drugs with potential signals of serious risks.