The Spanish Agency for Medicines and Health Products (AEMPS) has removed the VitaFer-L product, marketed as a food complement, since it presented an active substance destined to correct erectile dysfunction and had not been evaluated or authorized by the agency.
The AEMPS was aware of the fact through the National Police Corps and sent the aforementioned product to the Official Control Laboratory of the Agency. The analyzes confirmed the presence in the VITAFER-L complement of the active Tadalafilo substance in sufficient quantity to restore, correct or modify a physiological function-erectile dysfunction-through a pharmacological action.
This gives the product the legal condition of medication. However, since the active substance is not declared in the labeling, false information is offered about your safety. The Vitafer-L label barely indicates the presence of a series of amino acids, vitamins and minerals.
As explained by the Medicines Agency In a statementTadalafilo is indicated to restore the deteriorated erectile function through a selective phosphodiesterase inhibition 5 (PDE-5) that causes an increase in the blood flow of the penis.
PDE-5 inhibitors are contraindicated in patients with acute myocardial infarction, unstable angina, effort angina, heart failure, uncontrolled arrhythmias, hypotension (blood pressure less than 90/50 mmhg), un controlled arterial hypertension, accident history ischemic cerebral (ischemic stroke), as well as in patients with severe liver failure and in people with a history of anterior non -arteritic ischemic neuropathy or with degenerative hereditary disorders of the retina such as pigmentosa retinitis (a minority of these patients have genetic disorders of the phosphodiesterases of the retina).
The agency recalls that the consumption of Vitafer-L could lead, therefore, serious health damage by containing this active substance inhibitor of PDE-5 that, in addition to presenting the contraindications mentioned above, has numerous interactions with other medications. In addition, it can cause the appearance of other adverse reactions of diverse gravity such as cardiovascular, since its consumption has been associated with acute myocardial infarction, unstable angina, ventricular arrhythmia, palpitations, tachycardias, stroke and even sudden cardiac death. These interactions have been given to a greater extent in patients with a history of cardiovascular risk factors for which it would be contraindicated.
After considering all these risks, in addition to the fact that the VITAFER-L product has not been subject to evaluation and authorization prior to marketing by the AEMPS, the drug agency has decided to prohibit its commercialization as a precautionary measure as well as Ask for the market withdrawal from all available specimens.
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