Anvisa’s decision expands control over the marketing of these products, sometimes used without any medical indication
THE National Health Surveillance Agency (Anvisa) he decided, on Wednesday 16, to take the prescription in the purchase of medicines as OzempicWegovy and the like, indicated for the treatment of diabetes Type 2 e obesity.
The measure, approved unanimously during the public meeting of the Board of Directors, expands control over the sale of these products – today the requirement is to present the prescription at the time of purchase.
In practice, pharmacies will no longer be able to return the revenue to the consumer: the document will be maintained, as with the antibiotics and controlled medicines. The validity of revenues will be up to 90 days from the date of issue.
“This measure aims to protect the health of the Brazilian population, above all because a high number of adverse events related to the use of these drugs have been observed outside the nominations approved by Anvisa,” said the agency in a note.
The decision will come into force 60 days after the publication in the Official Gazette of the Union of Modification of resolution no. 471/2021In which the competitive medicine of the GLP-1 will also include, a category that includes semaglutide, liraglutide, dulaglutide, exented, type and waste.
Deviation of the purpose
According to the data presented during the meeting by Thamires Capello, a researcher at the USP Health Law Research Center, 45% of the people who use traffic semaglutide or tirzepatida drugs have no prescription. “And within this group, 73% report that they have never received any professional guide,” he said.
In addition, according to the survey, 56% of users use drugs with the aim of weight loss and 37% did not overweight or obesity, which reveals a deviation of purpose. “The trivialization of use compromises access to those who really need,” added Thamires. More than half of those who really need products (54%) reported finding the drug in sales points.
During the meeting, Renato Alencar Porto, interface representative, underlined the need to review the current regulation. “The current standard is no longer sufficient to contain improper use. We are witnessing advertising campaigns aimed at the general public, which is a clear violation of the health rules,” he said.
He also attracted attention to the significant increase in the illegal import of active pharmaceutical products, which indicates a possible large -scale production, overcoming the limits of individual use. “Between 2023 and 2025, Brazil imported 17.8 kg of traffic lights, enough to produce about 4 million ozepic pens. Already from Tirzepatida, which was not even approved in the country, there were 10 million doses, which would have given almost 2 million pens,” he said.
The discussion has been postponed twice
The obligation to preserve the prescription for the remedies of the GLP-1 competitive class began to be discussed in November last year. At the time, the replacement president of Anvisa, Rômison Rodrigues Mota, asked for a vision and the debate was postponed for March.
Last month, however, the problem was again postponed for the need for “technical study”. “As regards the principle of caution and responsibility, that this collegiate must be dealt with, and so that I can review this information and lead to the resolution of this collegiate a proposal not only based, but also just and technically feasible, I inform the directors and others that I am removing this object of agenda,” Mota said at the moment.
The delay generated criticisms of doctors and class entities. For them, revenue conservation would be a welcome attitude and uncertainty would end up damaging patients.
Source: Terra

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