Dinavisa warns about detection of counterfeit Botox

The United States and Brazil warned regarding batches of counterfeit Botox. Photo Courtesy.-

Asunción, IP Agency.- The National Directorate of Health Surveillance (Dinavisa) reports that it has learned through international agencies in the United States and Brazil regarding the falsification of botulinum toxin – Botox. Warning that its application for cosmetic purposes causes adverse effects, including hospitalizations due to its use.

In order to protect the health of the population, Dinavisa echoes the health alert issued by the National Health Surveillance Agency – ANVISA (Brazil); and by the United States Food and Drug Administration (FDA) on counterfeit Botulinum Toxin Botox 100U (botulinum toxin A).

Dinavisa informs the population that this agency does not have current Health Records for the aforementioned brand. Although the cosmetic product was found in other countries, the corresponding warning is given to professionals and patients, in the event of its possible entry into the country through smuggling.

Warnings from international agencies

Brazil’s Anvisa warns of new cases of counterfeiting of botulinum toxin Botox® 100U (botulinum toxin A). From last year to date, adulterated or falsified units of the following lots were identified: C7746C3 (val. 04/2025); C7211C4 (val. 08/2026); C3709C3 (val.05/2025); C6835C3 (val. 10/2024 and 12/2024); and C7654C3F.

Also, the US FDA alerted healthcare professionals and consumers that unsafe counterfeit versions of Botox (botulinum toxin) have been found in several states and have been administered to consumers for cosmetic purposes. The FDA is aware of adverse events, including hospitalizations, related to the use of counterfeit Botox.

Symptoms due to the application of counterfeit Botox

Symptoms include blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, difficulty breathing, weakness, and difficulty raising the head following injection of these products. These symptoms are similar to those seen when botulinum toxin spreads to other parts of the body.

recommendations

• Acquire medications that come from authorized pharmaceutical establishments.
• Purchasing and administering counterfeit products puts your patients at risk.
• Check the product for signs of counterfeiting before using it.
• Confirm with your healthcare professional that you are receiving a product from an authorized source.
• Ask your healthcare professional if he or she is licensed and trained to administer the product.