Tysabri and Ozempic: see lots of counterfeit medicines – 03/11/2023 – Health

Anvisa (National Health Surveillance Agency) issued an alert this Friday (3) regarding the circulation of counterfeit batches of Tysabri (natalizumab), for the treatment of multiple sclerosis, and Ozempic (semaglutide), indicated for adults with type 2 diabetes — the latter reported by Folha on October 25th.

Regarding Tysabri, Biogen Brasil, which holds the registration for the medication, stated that batch FF00336, valid until 01/2026, was produced only for institutional, and not commercial, purposes.

The batch referred to has characteristics that differ from those contained in the original medicine — spelling errors in the address of the company responsible for importing and distributing the product in the country,
difference in the color of the orange and blue strip on the packaging, formatting of the letters and absence of Braille inscription.

As for Ozempic, the pharmaceutical company Novo Nordisk does not recognize batch LP6F832 —valid until 11/2025— as original, making it a counterfeit.

The first record of drug fraud occurred in June. At the time, the agency reported that it was alerted by the manufacturer about the identification of counterfeit units on the market.

According to the pharmaceutical company, units from batch MP5C960 had a different concentration in their packaging than the original. The language (Spanish) also did not match that of the real batch.

The case was shared as a warning to international health agencies and, in August, Mexico reported counterfeits with the same batch.

The resolutions determining the seizure and prohibition of the commercialization, distribution and use of Ozempic and Tysabri were published in the Official Gazette of the Union.

WHAT TO DO

Anyone who identifies units of medicine suspected of being counterfeit must contact the companies holding the product registration to verify authenticity. Never use medication.

It is also recommended to communicate the fact to Anvisa, through the Notivisa system (in the case of a healthcare professional) or through the Ombudsman system, using the FalaBR platform (valid for patients).

According to the agency’s guidance, do not use websites and channels not licensed by Anvisa to sell medicines. Be suspicious if the box presents information in another language and data different from that found on the packaging.

Finally, be suspicious if the value is very different from that on the CMED (Medicine Market Regulation Chamber) price list. The list is published on the Anvisa website and updated monthly.

According to Luciana Canetto, vice-president of the CRF (Regional Pharmacy Council) of SP, medicines to lose weight, treat cancer and erectile dysfunction, for example, are among the biggest targets for counterfeiting due to the high price and great demand.

BE CAREFUL WHEN BUYING MEDICINES

The CRF advises that medicines be purchased from authorized locations, such as pharmacies, drugstores, distributors and manufacturers in the sector, and not from middlemen.

“You need to have a health license, operating authorization from Anvisa and a certificate of regularity, which is a document issued by the Regional Pharmacy Council”, says Canetto.

“Always check the packaging. Counterfeiting is not always done well. It often contains erasures in the batch or the batch is a little faded, the expiration date is somewhat altered. Check that the batch number on the inner packaging, which is on the blister, matches the batch number and validity of the outer box, because sometimes counterfeiters are unable to work with both packages in a coherent way”, adds the vice-president of the organization.