Anvisa warns of counterfeit batches of Ozempic and Tysabri medicines

The National Health Surveillance Agency (Anvisa) published, on Friday, 3, in its website, an alert to health professionals and the population about counterfeit batches of two medicines: Tysabri® (which contains the active substance natalizumab), indicated for the treatment of more active forms of multiple sclerosis, and Ozempic® (the active ingredient semaglutide), to treat, in conjunction with diet and physical activity, adult patients with type 2 diabetes, when the body does not produce insulin or creates resistance to it.

The warning about the medicine against sclerosis comes after the company that holds the registration, Biogen Brasil Produtos Farmacêuticos Ltda., communicated to Anvisa the identification, in the country, of the counterfeit of the biological product Tysabri (natalizumab), batch FF00336valid until January 2026. According to the laboratory, the batch was produced only for institutional, not commercial, purposes, and has characteristics that differ from those contained in the original medicine, sold in pharmacies.

In this case, Anvisa published in the Official Diary of the Union The Resolution 3,874/2023which adopts preventive measures, such as seizure and prohibition of distribution, sale and use of counterfeit products.

To identify items from the batch in question (FF00336), the company informs that there are spelling errors in the address of the company responsible for importing and distributing the product in the country, a difference in the color of the orange and blue stripe on the packaging, the formatting of the letters and the absence of Braille inscription on the packaging, dealing with It is therefore a forgery.

Regarding the falsification of Ozempic, Anvisa received another statement, this time from the company Novo Nordisk Farmacêutica do Brasil Ltda., responsible for the brand. The company denounced as false, in the Brazilian market, the batch LP6F832which would indicate it is valid until November 2025.

The Novo Nordisk laboratory does not consider this batch of pens to be valid and, therefore, it is a counterfeit product. The agency published the Resolution 3,945/2023which also determines the seizure and prohibition of marketing, distribution and use of counterfeit medicine.

In your website, Novo Nordisk advises consumers to be wary of very low prices, non-traditional sales points and reminds that Ozempic is only sold in pre-filled injectable pens. There is no other presentation.

Anvisa recommends that the population and healthcare professionals only purchase medicines from properly regulated establishments, always in complete packaging (inside the box) and with an invoice.

If medicine units suspected of being counterfeit are identified, the public or healthcare professionals should not use the product and should contact the companies that hold the registration for these items, to verify their authenticity.

Furthermore, the fact must be communicated immediately to Anvisa, preferably through the system Notivisa, in the case of a healthcare professional. Patients can now report the existence of counterfeit medicine to the ombudsman, through the platform FalaBRwith Login (CPF) and password registered on the portal Gov.br.

The history of irregular products already identified in Brazil can be consulted using Anvisa’s consultation system, available on its website.

For more information, the National Health Surveillance Agency has a public telephone call center (0800-6429782), available from 7:30 am to 7:30 pm, Monday to Friday, except holidays. The call is free throughout Brazil. / With information from Agência Brasil