Anvisa \u2013 the National Health Surveillance Agency \u2013 released a warning last month about the use of pens indicated for the treatment of obesity and diabetes without proper medical guidance.<\/p>\n
The statement issued involves different GLP-1 agonist medications, a group that includes substances such as dulaglutide, liraglutide, semaglutide, and tirzepatide, hormones that help control appetite and prolong the feeling of fullness, and highlights the importance of safe use within approved indications, given the recent increase in adverse event notifications in the country.<\/p>\n
According to the Agency, between 2020 and 2025, six suspected deaths and 145 notifications of pancreatitis possibly associated with the use of so-called \u201cslimming pens\u201d were registered. Although the risks \u2013 classified as severe but rare adverse events \u2013 are already foreseen in the package insert, the increase in the number of cases, including necrotizing and fatal forms, has prompted greater regulatory attention, with the Agency reinforcing the use of these products exclusively according to authorized indications, under prescription, monitoring by a qualified professional, and constant pharmacovigilance, in clear shared responsibility among manufacturers, prescribers, dispensers, and patients.<\/p>\n
Based on approved indications and current regulatory assessments, the benefit-risk profile has always been and remains favorable. To protect consumers, ANVISA only allows a medication to be placed on the market after years of studies mapping the risks associated with the product. From the perspective of the responsibility of manufacturers or importers who hold the sanitary registration for these drugs, it is vital to ensure that:<\/p>\n
Finally, it should be noted that pharmacovigilance data on adverse events during medication use constitute a safety signal, but do not determine a causal relationship. There has been no demonstration of direct causality to date, and the scenario reinforces the importance of multifactorial assessments, considering comorbidities, concomitant use of other drugs, and eventual off-label use, as well as the use of counterfeit or unknown origin products.<\/p>\n
In the United Kingdom, the regulatory authority MHRA \u2013 Medicines and Healthcare products Regulatory Agency reported that over 25 million packs of GLP-1 class medications have been distributed in the country over the last five years. Between 2007 and October 2025, 1,296 reports of pancreatitis associated with the use of these products were recorded, including 19 deaths and 24 episodes of necrotizing pancreatitis.<\/p>\n
The increase in reports has driven a growing movement to strengthen pharmacovigilance, provide guidelines for safe use, and revise the information in package inserts, in addition to monitoring prescription and dispensing.<\/p>\n
In Brazil, in June 2025, Anvisa published RDC 973\/25 and IN 360\/25, making it mandatory to retain the medical prescription for the dispensing of pens, in a model similar to that used for antibiotics. The rules now include:<\/p>\n
The measures adopted reinforce the responsibility of prescribers and dispensers and reduce the risk of off-label use and self-medication, potentially contributing to the mitigation of incidents related to inadequate use, as well as strengthening the evidence of compliance with the duty of information and vigilance on the part of manufacturers.<\/p>\n
The Brazilian regulatory agency also reiterated the need to register all adverse events in VigiMed3, a system intended for continuous monitoring of the safety of medicines and vaccines in the country, for the construction of a robust database and for the adoption of preventive measures.<\/p>\n
Weight loss pens based on GLP-1 agonists remain effective and safe when used as medically indicated. The scenario, however, reinforces the importance of coordinated risk management actions throughout the entire product lifecycle.<\/p>\n
Strengthening regulatory measures, along with continuous clinical monitoring and patient caution, becomes indispensable to ensure that therapeutic benefits safely outweigh potential risks. In this regard, reviewing package insert materials and promotional materials is relevant to ensure clarity, up-to-dateness, and adherence to Anvisa's requirements, reinforcing the fulfillment of the duty to inform.<\/p>\n
For the pharmaceutical industry, in particular, the improvement of pharmacovigilance and regulatory compliance programs is of interest, with:<\/p>\n
Especially in a context of undesired predatory litigation, deepening the training documentation for medical representatives and registering evidence of package insert updates and communication to healthcare professionals also tend to contribute to mitigating risks associated with the occurrence of adverse events.<\/p>\n
In summary, there is a need for continuous vigilance, clear communication, and responsible use of GLP-1 agonists at both national and international levels. This fact demands greater attention from various stakeholders to the integrated management of regulatory and legal risks and the robustness of pharmacovigilance programs, in addition to preventive strategies for mitigating existing risks.<\/p>","protected":false},"excerpt":{"rendered":"
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