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Spanish health agency withdraws five unlabelled erectile-dysfunction products in a week

The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) has removed five supplements containing undisclosed sildenafil or tadalafil after discovering they are effectively medicines.

In a rapid enforcement move, the Spanish Medicines Agency (AEMPS) has taken five erectile-function enhancers off shelves after laboratory tests revealed the presence of sildenafil or tadalafil, which were not declared on the labels. These substances classify the items as medicines, requiring a prescription, which the products falsely avoided by marketing themselves as natural supplements. The latest batch includes the brand El Toro, discovered by the Policía Nacional in Asturias, while four other products were removed earlier in the week, among them Etumax Royal Honey containing tadalafil.

This follows seven withdrawals earlier in the year for the same violation. AEMPS cautions that hidden PDE-5 inhibitors can trigger severe heart-related side effects such as arrhythmias, heart attacks, and strokes, especially in patients with existing cardiovascular conditions.

Why it matters

Undeclared drug ingredients in over-the-counter supplements pose serious health risks and bypass medical oversight.

In this story

sildenafiltadalafilPDE-5 inhibitorsunlabelled supplementscardiovascular riskAEMPSproduct withdrawal
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