Aemps (Spain's agency for medicines and health products) has ordered the withdrawal from the market of a product for erectile dysfunction because it contains ... the active substance sildenafil, which means it is classified as a medicinal product.
The product in question is sold under the name El Toro and, although this is not stated on the labelling, it contains a sufficient quantity of sildenafil to restore, correct or modify a physiological function by exerting a pharmacological effect, according to lab analyses.
Sildenafil treats impaired erectile function by increasing blood flow to the penis through the selective inhibition of the enzyme phosphodiesterase 5 (PDE-5).
The issue is that PDE-5 inhibitors are contraindicated in patients with various medical conditions, particularly those affecting the cardiovascular system. They have numerous interactions with other medicines and can cause significant adverse reactions. Among the most serious of these are acute myocardial infarction, unstable angina, ventricular arrhythmia, palpitations, tachycardia, stroke and even sudden cardiac death.
Furthermore, the Aemps reports that PDE-5 inhibitors are contraindicated in patients with acute myocardial infarction, unstable angina, exertional angina, heart failure, uncontrolled arrhythmias, hypotension (blood pressure below 90/50 mmHg), uncontrolled hypertension, a history of ischaemic stroke, in patients with severe hepatic impairment and in individuals with a history of non-arteritic anterior ischaemic optic neuropathy or hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).