[Expert Committee on Prescription Requirements against an OTC Switch for Sildenafil. A Good Decision! Really? A Nuanced Perspective.].

By resolution of January 21, 2025, the Expert Committee on Prescription Requirements (SVA), at its 90th meeting, rejected by majority vote the application to exempt Sildenafil 25 mg and Sildenafil 50 mg for oral use from prescription requirements. In its statement dated January 22, 2025, the German Society of Urology (DGU) welcomed this decision. "Unregulated intake due to unrestricted access to the active substance carries significant risks that can only be identified and avoided through medical prescription. Medical consultation and examination can rule out contraindications such as hypotension, severe cardiovascular disease, or certain eye conditions, and can also help to identify patient-specific risks, comorbidities, and the need for treatment. The primary reason for taking PDE-5 inhibitors like Sildenafil is erectile dysfunction, which has been scientifically proven to be an early warning sign of cardiovascular disease and must therefore be diagnostically evaluated. (…) With its current vote to maintain the prescription requirement, the committee once again sends the right signal for patient well-being." (Press release by DGU, January 22, 2025.) At first glance, this appears to be a reasonable argument. But does this perspective truly take into account all aspects related to the use of PDE-5 inhibitors and their availability?