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Rapid growth in the use of these medications in the country leads regulatory agency to intensify surveillance in hospitals and health services focusing on patient safety
The increase in the use of so-called slimming pens in Brazil has raised an important alert among health authorities. The information was released by “Anvisa“, through an official statement, highlighting the start of the implementation of the Active Pharmacovigilance Action Plan for GLP-1 agonist class medications. The measure aims to reinforce the monitoring of the safety of these medications under real use conditions, especially given the popularization of these substances in the country.
Currently, medications with active ingredients such as semaglutide, tirzepatide, and liraglutide have been widely used, not only in the treatment of type 2 diabetes mellitus but also in obesity control. However, the increase in demand and use outside the approved medical indications raises relevant concerns about the safety and potential adverse effects of these treatments.
Active pharmacovigilance seeks to identify risks in real time
In this scenario, Anvisa decided to adopt a more robust monitoring approach. Unlike the traditional model, which relies on spontaneous notifications, the new plan bets on active pharmacovigilance, which involves the direct search for adverse events in patients.
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To kickstart the implementation, the Agency gathered about 120 representatives from hospitals and health services. The strategy aims to engage these institutions in the qualified identification and investigation of potential adverse effects related to the use of GLP-1 pens.
Moreover, health services take on an even more central role in the national pharmacovigilance system. This is because they can observe, in practice, the behavior of these medications in different patient profiles.
This new model aims to reduce historical problems, such as underreporting and the low quality of clinical information. After all, many notifications do not include essential data, such as the dose used, treatment duration, medical indication, and origin of the medication.
With more complete information, Anvisa expands its ability to assess the relationship between medication use and potential adverse effects, as well as to identify risks more quickly.
Off-label use and online purchases increase risks for patients
Another point that drew attention during the plan’s presentation was the growth of off-label use of these medications. In other words, many patients use GLP-1 pens outside the approved indications in the leaflet, especially for aesthetic purposes.
This behavior significantly increases regulatory challenges. This occurs because the safety of these medications, in many cases, has not been evaluated for this type of use in clinical studies.
Additionally, Anvisa highlighted an even more serious problem: the purchase of these medications over the internet and through social networks. This practice may involve counterfeit products or those of unknown origin.
As a consequence, health risks increase considerably. Furthermore, this type of acquisition complicates the traceability of medications, compromises the quality of clinical information, and hinders sanitary surveillance actions.
Real-world data strengthens medication safety analysis
To make monitoring more efficient, Anvisa’s plan bets on the use of Real World Data (RWD). This approach allows for tracking the use of medications in real situations, outside the controlled environment of clinical studies.
The model provides for prospective monitoring, with a structured search for cases within health services. In this way, the Agency intends to improve the early detection of adverse events and enhance the quality of recorded information.
In addition, the collected data will be integrated into the VigiMed system, which centralizes adverse event notifications in Brazil. With this, Anvisa strengthens its database and improves its regulatory response capacity.
The project will initially be implemented as a pilot. It will involve hospitals from the Sentinela Network, federal university hospitals from the HUBrasil Network, and other interested institutions.
The Sentinela Network brings together health services, teaching and research institutions, as well as laboratories and pharmaceutical establishments. These institutions act as an active observatory of the safety and performance of health products in clinical practice.
Next steps include expanding monitoring and integrating the health system
In the coming months, Anvisa is expected to advance in formalizing the participation of the hospitals involved. In addition, the Agency will define technical responsibilities and effectively begin active monitoring of medications.
The monitoring will include substances such as semaglutide, liraglutide, dulaglutide, and tirzepatide. The analysis will cover registered, compounded products, and even cases with suspected counterfeiting.
With this initiative, Anvisa aims to strengthen the integration between assistance and regulation. At the same time, it seeks to expand the capacity of the National Health Surveillance System to transform clinical data into concrete evidence to protect the health of the population.
Therefore, the new plan represents an important step given the accelerated growth in the use of weight-loss pens in Brazil and reinforces the need for rigorous monitoring of these medications.
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