Four health supplements found to contain a drug used to treat impaired erectile function withdrawn from market in Spain

Isabel Méndez

Malaga

Saturday, 6 July 2024, 08:48

A warning from the Seprona branch of the Guardia Civil's headquarters in Malaga prompted Spain's Ministry of Health to withdraw from sale the following products: Miel d'Afrique, Royal Honey VIP, Jaguar Power and Royal Honey Plus.

According to analyses carried out by the Spanish Agency for Medicines and Health Products (AEMPS), these four stimulants contain the active substance sildenafil in sufficient quantity to restore, correct or modify a physiological function by exerting a pharmacological action, which gives them the legal status of being medicinal products. This substance is not mentioned on the labelling, but is presented as a natural product, concealing its true composition from the consumer. Sildenafil is a medicine, or drug, used to restore impaired erectile function by increasing penile blood flow by means of selective inhibition of the enzyme phosphodiesterase 5 (PDE-5).

As explained by AEMPS, PDE-5 inhibitors are a contraindication for patients with any of the most common heart problems such as all types of angina, acute myocardial infarction, heart failure, arrhythmia, anyone with hypotension (blood pressure below 90/50 mmHg) or hypertension, those with a history of strokes, severe hepatic impairment (liver not working) and in people with a history of several, hereditary, retinal disorders.

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Furthermore, these inhibitors should not be taken with quite a few other medications as they could cause adverse reactions of varying severity. Taking cardiovascular as an example, their use has been associated with acute myocardial infarction, unstable angina, ventricular arrhythmia, palpitations, tachycardia, stroke, and even sudden cardiac death. These adverse reactions have occurred to a greater extent in patients with a history of cardiovascular risk factors, so that is why they should have been labelled correctly with contraindications mentioned.

Considering the risks mentioned above, as well as the fact that these products have not been subject to evaluation and authorisation prior to marketing by AEMPS, the agency has taken the precautionary measure of prohibiting their marketing and has requested their withdrawal from sale and all product units to be removed from shelves.