Spain

Spain recalls Viagra-like supplement « Euro Weekly News



Spain recalls a supplement containing a hidden Viagra ingredient.
Credit : Anastassiya Bezhekeneva, Shutterstock

Spanish health authorities have ordered a sexual performance supplement to be taken off the market after laboratory testing found an unlisted drug component used in Viagra. Consumers who may have purchased the product are advised not to use it.

The Spanish Agency for Medicines and Medical Devices (AEMPS) announced the warning on October 7 after detecting sildenafil in a product called ‘El Toro,’ which is a dietary supplement.

Sildenafil is the active ingredient in Viagra and other medications that treat erectile dysfunction. The presence of Sildenefil was not disclosed on the product’s label, exposing consumers to pharmaceutical products that could have potentially dangerous side effects.

The agency has demanded the product be taken off the shelves, and Spain’s food safety authority is warning anyone who has bought it not to eat it.

Which supplement has been recalled in Spain?

El Toro is the name of the product under the alert. This is a liquid supplement produced by American Herb.

According to information from the Catalan Food Safety Agency on October 9, the product can be identified by the following information:

  • Product name: El Toro
  • Brand: American Herb
  • Presentation: Liquid supplement in a 120ml container
  • Best-before date: December 31, 2027

The warning was prompted by information that the AEMPS had received from the police headquarters in Asturias, which alerted the agency to the product’s sale.

The AEMPS Official Control Laboratories conducted further analysis and confirmed that the product contained sildenafil in sufficient quantity to have a pharmacological effect.

El Toro was presented as a natural product, but since its discovery, it is a medicine according to Spanish law. It had not been approved for sale as meds.

The problem is not just that the supplement contains sildenafil, but that people were not informed about it. This means that people who purchase the supplements had the chance of taking a pharmaceutical substance without being aware of its presence or any possible contraindications.

Spain’s Food Safety and Nutrition Agency (AESAN) then sent out the recall notice to all regions so that they could ensure that the product was being removed from the sales channels.

Why has the AEMPS warned of serious health risks?

Sildenafil is a medication used to treat erectile dysfunction by increasing blood flow to the penis. Sildenefil works by blocking the enzyme phosphodiesterase type 5 (PDE-5).

When prescribed and used properly, sildenafil has known medical uses. However, it is not suitable for everyone and may interact with other medications.

The AEMPS notes that PDE-5 inhibitors are not to be used in individuals with certain medical conditions, particularly those affecting the heart.

Unstable angina, uncontrolled heart rhythm disorders, low blood pressure, untreated high blood pressure and some types of heart failure are examples.

The agency also notes that a history of serious liver disease, an ischaemic stroke, and eye disorders can also be a risk factor for these medicines.

The AEMPS warns that using a product that contains an unlabelled PDE-5 inhibitor could lead to serious adverse reactions, such as palpitations, a fast heartbeat, irregular heartbeats, strokes and, in extreme cases, causing heart attack or sudden cardiac death.

These are potential risks identified by the regulator. They do not include reports of such events among those who use El Toro.

The problem is especially troubling for people who are already taking medication or have a preexisting condition such as heart disease. These individuals may not know that the supplement contains a substance that may interact with their medication.

The product’s natural presentation may also give consumers a misleading impression of its safety.

What should consumers do if they have El Toro at home?

Spain’s food safety agency has issued a strong recommendation: any consumer who has the affected product in their homes should not consume it.

Consumers can check the name, brand, packaging and expiration date against the information provided by the Catalan Food Safety Agency.

Anyone who has already used the supplement and is concerned about potential side effects or interactions with existing medications should consult with a healthcare professional. Any serious symptoms, such as chest pain, fainting or stroke symptoms, require immediate medical attention.

The authorities have not provided a specific number of people harmed by the product, nor does the official statement confirm that consumers have suffered specific injuries from taking it.

The warning also points to the risks of using natural supplements to replace prescribed drugs.

Unlike an approved medicine, a product with an undeclared active ingredient has not been evaluated and labeled in a way that makes it easy for consumers to know what they are taking and whether it is suitable for them.

Sexual performance supplements buyers in Spain can be aware that even natural supplements are not necessarily free of pharmaceuticals.

The AEMPS withdrawal of authorization is still the primary official measure to be applied, with food safety authorities in each region having to ensure that the contaminated product is removed from the market.




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