The AEMPS withdraws the El Toro product after discovering that it contained an undeclared erection drug

The Spanish Agency for Medicines and Health Products (AEMPS) has ordered the withdrawal from the market and the cessation of marketing of the El Toro product after detecting sildenafil in its composition, an active ingredient used to treat erectile dysfunction and which is not declared on its labeling.

The agency was aware of the marketing of the product through the Asturias Police Headquarters and, after the analyzes carried out by its Official Drug Control Laboratory (LOCM), confirmed the presence of sildenafil in a quantity sufficient to exert a pharmacological action. This circumstance means that the product is legally considered a medicine, despite the fact that it is presented as a natural product.

Sildenafil is the active ingredient in medications used to restore impaired erectile function. It works by increasing blood flow to the penis by selectively inhibiting the enzyme phosphodiesterase 5 (PDE-5). Therefore, although the AEMPS does not expressly classify El Toro as a "sexual stimulant", its content gives it an effect intended to improve erection.

The AEMPS warns that consumption of the product may pose a health risk, since the consumer is unaware of the presence and quantity of the active ingredient. PDE-5 inhibitors also have contraindications and may interact with other medications.

People for whom sildenafil is contraindicated include those who have suffered an acute myocardial infarction, suffer from unstable angina or heart failure, have certain arrhythmias, hypotension or uncontrolled arterial hypertension, have suffered an ischemic stroke or suffer from severe liver failure, among other situations.

Likewise, the AEMPS warns of possible serious adverse reactions, especially of a cardiovascular nature, including acute myocardial infarction, unstable angina, ventricular arrhythmias, palpitations, tachycardia or stroke. In certain cases, episodes of sudden cardiac death have also been described.

The agency points out that the problem also lies in the fact that sildenafil does not appear on the El Toro labeling, which presents the product as natural and, in this way, does not allow the consumer to know its true composition.