On Wednesday, April 16, 2025, Brazil’s National Health Surveillance Agency (Anvisa) announced a significant policy change regarding medications that agonize the GLP-1 hormone, commonly used to treat diabetes and obesity. This new regulation mandates that prescriptions for these medications must be retained at pharmacies, a shift that affects both injectable options like Ozempic and oral alternatives such as Rybelsus.
The Danish pharmaceutical company Novo Nordisk, which manufactures both Rybelsus and Ozempic, confirmed on April 17 that it received Anvisa's new prescription retention measure with "naturalness." The company acknowledged that the measure is not related to the safety or efficacy of the drugs but recognizes the necessity to curb irregular usage. "The company shares Anvisa's concerns regarding the irregular use of medications and off-label indications," stated Novo Nordisk in a press release.
Previously, patients could purchase these medications without a prescription, leading to widespread self-medication. This practice has raised alarms among health officials, as many individuals were using these powerful drugs without proper medical supervision. The new rule aims to ensure that only those with legitimate medical needs can access these medications, thereby addressing the issue of shortages faced by patients who truly need them.
Under the new regulations, prescriptions will be valid for 90 days, requiring patients to consult their healthcare providers regularly for treatment re-evaluation and dose adjustments. This measure is expected to improve the availability of these medications in pharmacies, as it will limit access to those who genuinely require them.
Rybelsus and Ozempic, both containing the active ingredient semaglutide, are part of a broader category of GLP-1 agonists, which also includes liraglutide, dulaglutide, exenatide, tirzepatide, and lixisenatide. These drugs have gained popularity due to their effectiveness in promoting weight loss, with some users experiencing a reduction of up to 17% in body weight within a year. However, the use of these medications without medical oversight can lead to serious health risks, including adverse reactions.
The decision to implement prescription retention was influenced by data from the Federal Council of Medicine (CFM), which highlighted the increasing and often inappropriate use of GLP-1 medications. Anvisa's director-president substitute, Rômison Rodrigues Mota, emphasized the importance of ongoing monitoring of these medications, as their long-term safety profile remains uncertain. He warned that prolonged use without proper medical evaluation could lead to complications, including metabolic alterations and other side effects.
Dr. Alessandra Rascovski, an endocrinologist and clinical director at Atma Soma, stressed, "Treatment with semaglutide should be accompanied by health professionals to ensure that the patient makes proper use of the medication, adjusts other medications that the patient is using, and adequately monitors side effects." This underscores the necessity for healthcare professionals to play an active role in managing treatments involving GLP-1 agonists.
In addition to the retention of prescriptions, pharmacies will be required to log the purchase and sale of these medications in the National System for the Management of Controlled Products (SNGPC). This systematic approach is designed to enhance accountability and traceability in the distribution of these drugs.
As the new policy takes effect 60 days after its publication in the Diário Oficial da União, it is expected to reshape how these medications are accessed in Brazil. With the growing concern over the misuse of GLP-1 medications, the initiative reflects a broader commitment to safeguarding public health.
The implications of this policy change extend beyond mere regulatory compliance. By ensuring that only patients with valid prescriptions can access these medications, Anvisa aims to mitigate the risks associated with self-medication and off-label use. The agency's actions are a response to alarming trends in the misuse of these powerful drugs, which were initially developed for diabetes management but have been increasingly used for weight loss.
As Brazil grapples with the challenges posed by the obesity epidemic and diabetes prevalence, the new prescription retention policy represents a critical step towards responsible medication use. It signals a renewed focus on patient safety and the importance of professional medical oversight in the treatment of chronic conditions.
In conclusion, the recent decision by Anvisa to enforce prescription retention for GLP-1 agonists is a proactive measure aimed at protecting public health. With the backing of pharmaceutical companies like Novo Nordisk, this initiative is set to ensure that medications are used appropriately, ultimately improving health outcomes for those who genuinely need them.
