RAÍSSA BASILIO
Novo Nordisk, a pharmaceutical company known for developing and marketing medicines such as semaglutide, the active ingredient in Ozempic and Wegovy, reported being aware of reports involving 10 deaths and 144 hospitalizations due to ingestion of false medicines, as reported by Reuters.
The cases occurred in the United States and concern people who consumed copies of their weight loss and diabetes treatment medications.
The company asked the FDA (Food and Drug Administration, a US regulatory agency) to prohibit compounding pharmacies from manufacturing copies of these medicines, citing safety concerns, as they are too complex products to be produced safely outside the formal chain. .
“We are deeply concerned about companies that promote and sell manipulated versions and copies not approved by the FDA and Anvisa [Agência de Vigilância Sanitária] of semaglutide, as well as sources that spread false information about GLP-1s [classe de medicamentos que imitam a ação do hormônio GLP-1, usado no controle da glicemia e no tratamento da obesidade] to the public. These copies present significant risks to safety and health”, informs the laboratory in a press release.
According to reports submitted by Novo Nordisk to the FDA, 144 patients in the United States were hospitalized and 12 died after taking compounded versions of semaglutide. The FDA warned that these incidents may represent only a small part of the problem, since adverse events from irregular medications are underreported.
Information about the sale of irregular semaglutide in Brazil is being evaluated by Anvisa, but Novo Nordisk is unaware of any cases of deaths related to the use of this substance in Brazil so far.
Cases of Ozempic counterfeiting in Brazil have already been identified in Brasília and Rio de Janeiro. The fake products caused hospitalizations.
According to the pharmaceutical company, all of its products “undergo a rigorous efficacy and safety assessment in large clinical studies carried out globally”, which include studies conducted in different countries to test their efficacy and safety.
Novo Nordisk then prepares a complete report with the information obtained, which is sent to the local regulatory agency – in the case of Brazil, Anvisa – for analysis and approval. Only after this approval can the medicines be sold.
The laboratory also says that it has taken measures to protect patients and warn them about these dangers, including correcting information, education campaigns, legal actions, continuous testing of samples and, more recently, the inclusion of semaglutide on the FDA lists of medications that are very complex to handle. Similar discussions are ongoing with Anvisa.
The company is the only one that holds the patent for semaglutide and has medicines with this active ingredient approved by both the FDA (regulatory agency in the United States) and Anvisa (regulatory agency in Brazil).
These substances, available only under medical prescription, include Wegovy, indicated for the treatment of obesity and overweight with comorbidities, Ozempic and Rybelsus, both indicated for the treatment of type 2 diabetes.
If you have any questions about irregular medicines in Brazil, the company informs that you can access a specific Novo Nordisk page to obtain more information.
CASES OF OZEMPIC COUNTERFEIT IN BRAZIL
Fake products in Brazil caused hospitalizations, including the hospitalization of a 46-year-old economist at Copa D’Or Hospital with severe hypoglycemia, according to Folha’s findings.
She bought the medicine at a pharmacy in the south of Rio. The Rio Civil Police opened an investigation, and the suspected product was sent for examination.
Novo Nordisk, manufacturer of Ozempic, confirmed the cases of counterfeiting, with suspicions that Fiasp and FlexTouch insulin pens were re-adhesive to look like Ozempic. The company is collaborating with authorities and has advised consumers to check the authenticity of the pens.
Rede D’Or alerted its hospitals about possible cases of use of counterfeit Ozempic. In January, the WHO (World Health Organization) issued a warning about the increase in counterfeit medicines due to global shortages of products. In Brazil, three counterfeit batches have already been identified by Anvisa.
In São Paulo, thefts of Ozempic by specialized gangs have led pharmacies to reduce their stocks.
