RegulatoryOfficial

AEMPS orders withdrawal of Enerup Premium over undeclared sildenafil

🇪🇸 AEMPS · Thu 22 Oct 2026

Spain's medicines agency says the product sold as 'natural' contains an undeclared PDE-5 inhibitor, which makes it a medicine in law, and has ordered it off the market.

The Spanish Agency for Medicines and Medical Devices (AEMPS) has ordered Enerup Premium to cease marketing and be withdrawn from the market. The agency says the product contains sildenafil, which is not declared on its labelling. The notice is referenced ICM (MI), 06/2026.

AEMPS learned of the product through the Spanish National Police, which reported that it was being sold as a natural product. Analysis by the agency's Official Medicines Control Laboratory (LOCM) confirmed sildenafil at a level sufficient to exert a pharmacological action. The agency says this gives the product the legal status of a medicine. The label presents the product as natural and does not tell consumers its real composition.

Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for erectile dysfunction. AEMPS lists contraindications for the class, including acute myocardial infarction, unstable angina, exertional angina, heart failure, uncontrolled arrhythmias, hypotension below 90/50 mmHg and uncontrolled hypertension. It also lists a history of ischaemic stroke, severe hepatic impairment, non-arteritic anterior ischaemic optic neuropathy and hereditary degenerative retinal disorders such as retinitis pigmentosa.

The agency warns that the product can cause serious harm because of these contraindications and its many interactions with other medicines. Reported adverse reactions include myocardial infarction, unstable angina, ventricular arrhythmia, palpitations, tachycardia, stroke and sudden cardiac death. AEMPS notes that these interactions and reactions have been seen more often in patients with cardiovascular risk factors, for whom the active substance is contraindicated.

What it means for your team

  • PV teams should be alert to adverse event reports involving products sold as 'natural' for erectile dysfunction, particularly cardiovascular events, as these may involve undeclared sildenafil.
  • Quality and compliance teams should note that undeclared active substances at pharmacologically active levels can make a supplement-style product a medicine in law, as AEMPS found here.
  • Teams monitoring illegal or adulterated products in Spain should add Enerup Premium to their watchlists and check online and retail channels for it.

Official source: AEMPS ↗

Article written by VigiEye from the official source (AEMPS). AI-assisted; check the source before acting.

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