The Spanish Agency for Medicines and Health Products (AEMPS) has ordered the prohibition of the commercialization and the recall of all copies of the product ‘HARD MAN capsules’ for containing an active principle against erectile dysfunction, tadalafil.
AEMPS has learned through the SEPRONA Section of the Santander Civil Guard Command, within the framework of Operation Pangea XIV, of the commercialization of the product ‘HARD MAN capsules’. As indicated on its labeling, this could have been marketed by the R-Vitality company.
‘HARD MAN CAPSULES’ is marketed as a food supplement, despite not having been notified of its placing on the market to the competent authorities, in breach of the provisions of current regulations for this type of products.
According to the analyzes carried out by the Official Control Laboratory of this Agency, the product contains the active substance tadalafil in sufficient quantity for restore, correct, or modify a physiological function exercising a pharmacological action, which gives it the legal status of a drug. This substance is not declared on its labeling, which misleadingly indicates a series of products of plant origin.
Tadalafil is indicated for restore erectile function impaired by increasing penile blood flow, by selective inhibition of phosphodiesterase 5 (PDE-5). PDE-5 inhibitors are contraindicated in patients with heart attack acute myocardium, unstable angina, exertional angina, heart failure, uncontrolled arrhythmias, hypotension (blood pressure <90/50 mmHg), uncontrolled hypertension, history of ischemic stroke (ischemic stroke), in patients with severe liver failure and in people with a history of non-arteritic anterior ischemic optic neuropathy, or with inherited degenerative retinal disorders, such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Selective PDE-5 inhibitors have numerous interactions with other medications, and adverse reactions of varying severity may also appear to take into consideration, such as cardiovascular ones, since their consumption has been associated with acute myocardial infarction, unstable angina, ventricular arrhythmia, palpitations, tachycardias, cerebrovascular accident and even sudden cardiac death, which They have occurred to a greater extent in patients with a history of cardiovascular risk factors for which it would be contraindicated.
‘HARD MAN cápsulas’ It is presented as natural, hiding its true composition from the consumer and giving misleading security information. In particular, the presence of tadalafil poses a risk for people who are especially susceptible to adverse reactions with the consumption of PDE-5 inhibitors.
Precisely, these people could resort to products of this type, supposedly natural, based on plants, as a theoretically safe alternative to authorized prescription drugs. These products are further presented with an emphasis on su supposed safety, misleadingly based on its natural composition.