Spain's national health authority has ordered the market prohibition and withdrawal of El Toro, a sexual stimulant marketed as natural, after chemical analysis revealed it contains undeclared prescription drugs.
The Spanish Agency for Medicines and Health Products, known as AEMPS, initiated the enforcement action after receiving notifications regarding the commercial distribution of the product from the Superior Police Headquarters of Asturias.
Subsequent laboratory testing conducted by the agency's Official Control Laboratory confirmed that El Toro contains sildenafil in amounts sufficient to exert a direct pharmacological effect on the human body.
Although the product was offered to consumers as an all-natural supplement, the manufacturer concealed its true composition by omitting sildenafil from the product labeling. Under Spanish pharmaceutical regulations, products containing active medicinal substances in therapeutic doses are legally classified as medicines and cannot be sold without regulatory authorization.
AEMPS is an autonomous regulatory agency attached to the Spanish Ministry of Health. It is responsible for guaranteeing that all pharmaceutical products, medical devices, and health goods sold in Spain meet strict safety, quality, and efficacy standards.
Undisclosed risks for cardiac patients
Sildenafil is a pharmaceutical substance indicated for the treatment of erectile dysfunction. It works by selectively inhibiting phosphodiesterase type 5, an enzyme that regulates blood flow, thereby increasing blood circulation to the penis to restore impaired erectile function.
Health officials warned that phosphodiesterase type 5 inhibitors carry severe contraindications for individuals with underlying medical conditions. The agency noted that the substance must never be taken by patients with acute myocardial infarction, unstable angina, exertional angina, heart failure, or uncontrolled cardiac arrhythmias.
The prohibition also applies to individuals suffering from hypotension with blood pressure readings below 90 over 50 mmHg, uncontrolled arterial hypertension, severe hepatic impairment, or a history of ischemic stroke.
In addition, health authorities highlighted that the hidden drug poses grave risks to patients with a history of non-arteritic anterior ischemic optic neuropathy or hereditary degenerative retinal disorders such as retinitis pigmentosa, a condition linked to genetic variations in retinal phosphodiesterases.
Potential for fatal complications
AEMPS cautioned that consuming El Toro can lead to severe health damage due to dangerous interactions between phosphodiesterase type 5 inhibitors and other prescription medications.
Regulators warned that potential adverse reactions include myocardial infarction, unstable angina, ventricular arrhythmia, palpitations, tachycardia, stroke, and sudden cardiac death.
According to the regulatory body, these adverse events occur with higher frequency in patients with pre-existing cardiovascular risk factors, for whom phosphodiesterase type 5 inhibitors are strictly contraindicated.
In legitimate medical practice, phosphodiesterase type 5 inhibitors like sildenafil require a physician's prescription and medical evaluation before use. Combining these substances with nitrate medications commonly prescribed for heart conditions can cause catastrophic drops in blood pressure.
Regional health authorities across Spain have been instructed to monitor retail channels to ensure all remaining packages of El Toro are removed from sale.
