The Spanish Agency for Medicines and Health Products (AEMPS) has ordered the prohibition of marketing and the withdrawal from the market of all copies of the products ‘Mero Macho’ and ‘Mero Macho Premium’, male sexual enhancers, due to the presence of sildenafil , the active principle of ‘Viagra’, despite the fact that it is not indicated on its labeling.
According to the analyzes carried out by the Official Control Laboratory of the AEMPS, under the Ministry of Health, these products contain the active substance sildenafil “in sufficient quantity to restore, correct or modify a physiological function by exerting a pharmacological action, which confers the legal status of medicine”.
However, these products have not passed any regulatory control and the substance is consequently not declared on their labeling, which misleadingly indicates a number of products of plant origin.
Sildenafil is indicated to restore impaired erectile function by increasing penile blood flow, by selective inhibition of phosphodiesterase 5 (PDE-5).
PDE-5 inhibitors are contraindicated in patients with acute myocardial infarction, unstable angina, exertional angina, heart failure, uncontrolled arrhythmias, hypotension (blood pressure < 90/50 mmHg), uncontrolled hypertension, history of ischemic stroke stroke (ischemic stroke), in patients with severe hepatic impairment and in people with a history of non-arteritic anterior ischemic optic neuropathy, or with inherited degenerative disorders of the retina, such as retinitis pigmentosa (a minority of these patients have genetic phosphodiesterase disorders of the retina).
The Spanish Agency for Medicines and Health Products has learned, through the Municipal Police of Madrid, of the marketing of these products, which they claim to be effective for up to two days, although it has not been able to identify the company responsible for their commercialization.
