Ozempic: see lots of counterfeit products – 10/25/2023 – Health

Ozempic counterfeiting, a problem that has gained prominence in recent weeks in Europe, also occurs in Brazil.

Resolutions from Anvisa (National Health Surveillance Agency) published in the Official Gazette of the Union indicate at least two episodes of fraudulent products and one of irregular dissemination of the medicine, which is indicated for the treatment of type 2 diabetes, but has become popular as an aid in the process of weight loss.

Last week, Anvisa was alerted by Novo Nordisk, responsible for manufacturing the medicine, that the pharmaceutical company does not recognize batch LP6F832, valid until November 2025, as original, meaning it is 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.

In addition to the fake medicines reported to Anvisa, there are also cases of compounding pharmacies selling what they claim to be the product without authorization, says the SBD (Brazilian Diabetes Society).

“The only semaglutide approved in Brazil [para tratamento de diabetes] It has the brands Ozempic (injectable) and Rybelsus (oral). There are no generics or biosimilars of semaglutide”, says João Salles, endocrinologist at Santa Casa de São Paulo and vice-president of SBD.

He also emphasizes that the drug is approved for type 2 diabetes and should only be used with a medical prescription. “The use of this medication without a specific titration causes important side effects in the patient.”

Hospitalized patients

In June, counterfeit applicator pens were found in the United States, and this month the European Medicines Agency issued a warning after being informed about the problem in legal and illegal supply chains in countries such as Germany and Austria.

In Austria, the health security office updated the statement issued on the 19th to inform that several patients in the country had to be hospitalized after using counterfeit versions of the medicine.

“The serious side effects reported, including hypoglycemia and convulsion, are an indication that the fake product contained insulin instead of the active ingredient semaglutide,” warned the Austrian authority.

According to Novo Nordisk, Ozempic products from batches MP5E511 and NP5G866, ​​involved in the European episodes, were not distributed in Brazil.

The pharmaceutical company states that it works with companies specialized in monitoring and eliminating the illegal supply of products and continues to report to the authorities all cases of counterfeiting that it is aware of.

Care when purchasing medicines

• 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 those found on the medicine packaging;
• 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;
• If you suspect counterfeiting, alert Anvisa.