T he National Institute for Drug and Food Surveillance (Invima) issued an alert about a sexual enhancer that is being marketed in the country without registration and which according to the FDA, may have serious health consequences.
According to the entity, the product marketed as red mammoth capsules, since it is not protected under a health registry, is considered a fraudulent product that does not guarantee compliance with quality, safety and effectiveness criteria, so its sale in Colombia is illegal.
According to the Invima statement, it was from the Food and Drug Administration (FDA), in the United States, that the first alerts were issued warning consumers to avoid certain products found on Amazon, eBay and other retailers; due to hidden and potential drug ingredients dangerous.
Faced with this, as read in the Invima alert, Amazon, following the FDA's call for attention to ensure that these products are not marketed on its platform, explained that, “laboratory analysis found that the product was contaminated with sildenafil and tadalafil, ingredients known as phosphodiesterase inhibitors (PDE) -5) found in FDA-approved products for the treatment of male erectile dysfunction.”
Thus, “the presence of sildenafil and tadalafil in the Red Mammoth Capsules makes the product an unapproved drug for which safety and efficacy have not been established and is therefore subject to recall.”
Therefore, Invima also “calls on citizens to always verify the health registration number of the product before using it, verifying its authenticity through the website www.invima.gov.co in online consultations and services by going to “check Registries Sanitary”, selecting in a group the type of product (medicine, dietary supplement, etc.), choosing in the search options by product name, health record or active ingredient”.
Faced with this, Invima announced the measures to be taken by the community in general:
1. Refrain from acquiring Red Mammoth capsules with the characteristics previously described.
2. Do not buy medicines or dietary supplements without a valid health record, as these products may contain ingredients that put your health at risk. Keep in mind that many of these fraudulent products are marketed on websites, social networks and WhatsApp networks.
3. If these products are consumed, you should:
a) Immediately discontinue use, due to the risks it may pose to your health
b) Immediately inform Invima or territorial health entities the data it knows about the places where these products are distributed or marketed.
c) If there are any adverse events associated with their consumption, they must be reported immediately as indicated on the Invima website in the menu Drugs and Biologics > Online Consultations and Services > PRM Report by Patients and other actors of the Colombian Health System.
4. Immediately inform Invima or territorial health entities if for any reason there is knowledge of places where these products are distributed or marketed.
Invima also called on the National Pharmacovigilance Network for “institutional pharmacovigilance programs to actively search for adverse reactions involving the aforementioned products and notifying Invima”.
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