Health withdraws five supplements for erectile dysfunction in just one week

The Spanish Agency for Medicines and Health Products (AEMPS) has focused this week on the sale of products for male erectile dysfunction that contain a substance for which medical control is necessary, since it is contraindicated in certain patients and can also have serious adverse reactions. The component in question is sildenafil, present in five items sold as supplements for this disability, and which have already been withdrawn from the market.

The first notice took place on October 2, when the AEMPS notified on its website of the withdrawal and cessation of marketing of four products: Etumax Royal Honey, Miel Soudan VIP, Epimedyumlu Macum and Organic Honey. All of them contained "sildenafil not declared on the label", which gives them the status of medications and would require a prescription. It was the Toledo Civil Guard Command that notified the agency of the sale of these products, and after the relevant analyzes carried out by the AEMPS Official Control Laboratory they were able to detect this substance.

Days later, on October 7, the health agency reported the withdrawal of a fifth product, El Toro, for the same reason: containing sildenafil not declared on its labeling. In this case, it was through the Asturias Police Headquarters that became aware of the marketing of this article.

As detailed in separate statements, these five supplements contain this active substance "in sufficient quantity to restore, correct or modify a physiological function by exerting a pharmacological action." Furthermore, "it does not appear on the labeling", which presents these products as "natural" and "hides" their true composition from the consumer.

In addition to sildenafil, one of these products, Etumax Royal Honey, contained the active ingredient tadalafil, while Organic Honey included paracetamol.

Both sildenafil and tadalafil are substances indicated for the treatment of erectile dysfunction in adult men by increasing blood flow to the penis by selective inhibition of the enzyme phosphodiesterase 5 (PDE-5).

Contraindications and adverse reactions

These PDE-5 inhibitors, explains the AEMPS, are "contraindicated" in people with acute myocardial infarction, unstable angina, effort angina, heart failure, uncontrolled arrhythmias, hypotension (blood pressure less than 90/50 mmHg), uncontrolled arterial hypertension, ischemic stroke, patients with severe liver failure and others with a history of a type of ischemic optic neuropathy or with hereditary degenerative retinal disorders.

As they warn, consuming these products "could cause serious damage to health", since, in addition to these contraindications, it has numerous interactions with other medications.