Impact of Switch to Non-Prescription Status on the Safety Profile of Sildenafil and Tadalafil: Assessment of Pharmacovigilance Databases
Abstract
Introduction: Sildenafil and tadalafil are phosphodiesterase type 5 inhibitors used to treat erectile dysfunction. In recent years, both medicines have increasingly been made available as Non-Prescription (non-Rx) or Over-TheCounter (OTC) medications in several countries. This analysis aimed to assess if these switches from prescription to non-Rx status had any impact on the safety profile of these medicines. Method: Individual Case Safety Reports (ICSRs) for sildenafil and tadalafil were retrieved from EudraVigilance, FAERS and SMARS databases for countries where these drugs switched to non-prescription status. Annual ICSR numbers, reporting rates and adverse event characteristics were analyzed before and after the switch dates. Results: Increases in annual ICSR numbers were observed over time for most countries. However, these trends coincided with increasing drug exposure and general increases in adverse event reporting. When adjusted for exposure and probable duplicate reports, no clear increases in reporting rates were associated with the prescription status changes. Reported adverse events remained consistent with the known safety profiles. No trends in patient age or use of contraindicated medications were identified. Discussion: The available data from EudraVigilance, FAERS and SMARS databases was thoroughly reviewed to identify the trends of reported AEs following pre and post OTC switch, however, the analysis was limited in some countries by low case counts , the…
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