– AEMPS
MADRID 23 Mar. (EUROPA PRESS) –
The Spanish Agency for Medicines and Health Products (AEMPS) has reported this Monday of the prohibition of marketing and withdrawal from the market of the products ‘La Pepa Negra tablets‘ and ‘Royal Honey‘, sold as natural food supplements, despite including an active ingredient that gives them the status of medicines, without having been evaluated or authorized by the agency.
According to the analyzes carried out by the Official Drug Control Laboratory (LOCM) of the AEMPS, these products contain the active substance sildenafil, indicated to restore impaired erectile function by increasing penile blood flow by selective inhibition of the enzyme phosphodiesterase 5 (PDE-5).
The active ingredient, included in sufficient quantity to restore, correct or modify a physiological function by exerting a pharmacological action, is not declared on the labeling of the products, which are presented as natural, hiding its true composition from the consumer.
The AEMPS has warned that PDE-5 inhibitors are contraindicated in patients with acute myocardial infarction, unstable angina, effort angina, heart failure, uncontrolled arrhythmias, hypotension, uncontrolled arterial hypertension, history of cerebral ischemic attack, as well as in patients with severe liver failure and in people with a history of non-arteritic anterior ischemic optic neuropathy or with hereditary degenerative retinal disorders such as retinitis pigmentosa.
In addition, it has been pointed out that this active ingredient has numerous interactions with other medications and can cause reactions of varying severity, especially of a cardiovascular nature, such as acute myocardial infarction, unstable angina, ventricular arrhythmia, palpitations, tachycardia, stroke and even sudden cardiac death. For all these reasons, the AEMPS has warned that its consumption could cause serious damage to health.
Considering the risks described, as well as the fact that these products have not been evaluated or authorized prior to their commercialization by this agency, the AEMPS has taken as a precautionary measure the prohibition of their commercialization and the withdrawal of all their specimens from the market.