The Ministry of Health, Social Services and Equality has prohibited the marketing and ordered the withdrawal from the market of all copies of the food supplement in capsule form ‘Vegetal Vigra’, for including in its composition sildenafil, the active principle of the popular drug for erectile dysfunction ‘Viagra’ (Pfizer).
The Spanish Agency for Medicines and Health Products (AEMPS), dependent on the department of Ana Mato, has learned through the Civil Guard of Madrid that this product, manufactured by the company Hand-Shaking, is being marketed in Spain as a supplement food, as they have verified in the framework of the Operation Pangea VII of fake medicines.
This product had not been notified to the competent authorities, in accordance with the provisions of current regulations and, according to the analyzes carried out by the Official Control Laboratory of this Agency, it contained sildenafil –despite the fact that it was not included or declared on its labeling– in a sufficient quantity to restore a physiological function exerting a pharmacological action, which gives it the legal status of medication.
As the AEMPS recalls, sildenafil works by restoring erectile function impaired by increasing penile blood flow by selective inhibition of phosphodiesterase 5 (PDE-5).
However, it is 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 (ischemic stroke). ).
Its use is also not recommended in patients with severe hepatic insufficiency. and in people with a history of non-arteritic anterior ischemic optic neuropathy or with hereditary degenerative disorders of the retina such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
In addition, the AEMPS warns, the active principle has numerous interactions With other medications, adverse reactions of varying severity may appear to be taken into consideration, such as cardiovascular, since its use has been associated with acute myocardial infarction, unstable angina, ventricular arrhythmia, palpitations, tachycardia, cerebrovascular accident, even sudden death. heart disease, which have occurred to a greater extent in patients with a history of cardiovascular risk factors.