Paraguay's National Directorate of Health Surveillance (Dinavisa) has once again issued a health alert regarding the domestic circulation of counterfeit Botox 100U (Botulinum Toxin Type A) products. Notably, this product lacks official health registration in Paraguay, making its import, distribution, and use all illegal, which could pose a severe public health risk.

Details of Counterfeit Product and Detection Status 

The counterfeit Botox product in question is labeled 'Botox 100U (toxina botulínica tipo A)' with lot number C7746C3 and an expiration date of April 2025. This product was discovered in Ciudad del Este, Alto Paraná, a major city in eastern Paraguay. Dinavisa emphasized that this product is being illegally distributed without the official approval of Paraguayan health authorities.

Repeated Warnings and International Cooperation 

Dinavisa previously issued a health alert for counterfeit Botox with the same lot number last year. At that time, the counterfeit status of the product was confirmed in Paraguay following a warning from the Brazilian National Health Surveillance Agency (Anvisa). This highlights the seriousness of cross-border counterfeit medicine distribution and underscores the importance of information sharing and cooperation among neighboring countries. Such repeated warnings indicate the need for consumers and medical professionals to verify product authenticity even more thoroughly.

Serious Health Risks of Counterfeit Botulinum Toxin 

Botulinum toxin type A is a specialized pharmaceutical product primarily used in cosmetic procedures. It is classified as a high-risk drug that can cause severe side effects if misused. Dinavisa warns that using counterfeit products can lead to the following serious health risks:

Absence or Poor Quality of Active Ingredient: Counterfeit products may contain no active ingredient, insufficient amounts, or contaminated ingredients. This can result in a lack of therapeutic effect or, conversely, unexpected side effects.
Serious Side Effects and Poisoning: Due to impurities or unidentified ingredients, severe side effects such as allergic reactions, nerve damage, respiratory distress, and even symptoms similar to botulinum poisoning can occur. These situations can be life-threatening.
Risk of Infection: Counterfeit products manufactured in unsanitary conditions can be contaminated with bacteria or viruses, increasing the risk of secondary infections, such as injection site infections.
A Dinavisa official repeatedly emphasized, "Counterfeit botulinum toxin can cause serious side effects, lack of therapeutic effect, or poisoning in patients. It is crucial to remember that such drugs are high-risk pharmaceuticals with strictly limited use."

Recommendations for Consumers and Healthcare Institutions 

Dinavisa strongly urges the people of Paraguay, healthcare professionals, and pharmaceutical distributors to strictly adhere to the following:

Verify Product Authenticity: When purchasing medicines, always buy through officially authorized distribution channels and meticulously check the product packaging, labels, and serial numbers to verify authenticity.
Do Not Use Suspicious Products: Never use products with an unclear origin, those that appear suspicious, or those that lack a registration number from Paraguayan health authorities. In particular, avoid purchasing products sold on social media or in unauthorized locations.
Check Health Registration: All medicines must have a Health Registration Number (Registro Sanitario) clearly stated on the packaging, issued by Dinavisa. You can verify the validity of this registration number on Dinavisa's official website (www.dinavisa.gov.py) to confirm genuine products.
Report Suspicious Cases Immediately: If you discover a product suspected of being counterfeit or illegally distributed, or if you experience side effects during use, report it to Dinavisa immediately.
 

How to Report 

If you find counterfeit medicines, you can report them to Dinavisa through the following methods:

Email: postcomercializacion@dinavisa.gov.py
Online: Through the reporting section on Dinavisa's official website
In-person: By visiting the Dinavisa office directly (Iturbe 883, near Manuel Domínguez) and submitting a written report.
Dinavisa stated, "To protect the health and safety of our citizens, we are strengthening our surveillance of counterfeit medicine distribution, and we request the active cooperation of all citizens and healthcare institutions in our efforts to eradicate illegal products." This warning aims to raise public awareness about the dangers of illegal medicine distribution and provide consumers with the necessary information to protect their own health. Vigilance and caution against illegal products are more crucial than ever.

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