On Wednesday, April 16, 2025, Brazil's National Health Surveillance Agency (Anvisa) announced a significant regulatory change requiring the retention of medical prescriptions for the sale of specific medications used in obesity treatment, including Ozempic, Wegovy, and Saxenda. This decision aims to enhance control over the use of these medications, which have gained popularity for weight loss, often without proper medical supervision.
The move came after the Conselho Federal de Medicina (CFM), Brazil's Federal Council of Medicine, issued a letter advocating for stricter controls around these drugs. The CFM highlighted the urgent need for regulation due to the rising instances of inappropriate use, particularly among patients seeking rapid weight loss without medical guidance.
Under the new regulations, prescriptions for these medications must be retained at pharmacies, similar to the existing rules for antibiotics. Rômison Rodrigues Mota, the interim president of Anvisa, stated, "For the agency to have information that allows effective monitoring of such products and thus support regulatory actions, prescription retention is, at this moment, the only regulatory alternative." This change marks a shift in how these potent medications are controlled, aiming to curb their misuse.
The new rule will be published next week and is set to take effect 60 days after publication. Anvisa will monitor the impact of this measure over the following 12 months. The prescriptions will remain valid for 90 days, ensuring that patients still have access to necessary medications while preventing excessive or inappropriate use.
Historically, medications such as Ozempic and Wegovy, which contain the active ingredient semaglutide, have been prescribed primarily for managing diabetes. However, their effectiveness in promoting weight loss has led to a surge in demand, often from individuals without diabetes seeking aesthetic benefits. According to Anvisa, approximately 92% of the 1,165 notifications of off-label use pertained to medications containing liraglutide and semaglutide, raising serious concerns about health risks associated with unsupervised consumption.
The decision to implement prescription retention aligns with a broader public health initiative to address obesity, which is recognized as a global health challenge. The World Health Organization (WHO) has indicated that obesity is a multifactorial condition influenced by various factors, including genetics, environment, and lifestyle.
Studies have shown that the use of weight-loss medications can yield results comparable to bariatric surgery, with semaglutide, for instance, promising reductions of up to 17% in body mass over a year. Furthermore, semaglutide can lead to a decrease in caloric intake by 30% to 40%, depending on dosage.
However, the burgeoning popularity of these medications has prompted concerns from health professionals. The Sociedade Brasileira de Endocrinologia e Metabologia (SBEM), along with other medical associations, has warned about the potential dangers of unregulated use. They stated, "Despite the efficacy of these medications for treating diabetes and excess weight, inappropriate and abusive use has become a growing concern. Therefore, it is essential that regulations are improved to ensure the safe and responsible use of these therapies."
While many medical professionals support the new regulations, there are concerns about the potential for overly stringent rules to hinder access for patients who genuinely need these treatments. The SBEM and other organizations have suggested that a balanced approach is necessary, advocating for controlled prescriptions that could allow for longer validity periods and multiple refills. This would help prevent misuse while ensuring that patients with chronic conditions can continue their treatments without unnecessary barriers.
In response to the announcement, the pharmaceutical industry expressed skepticism. The Associação da Indústria Farmacêutica de Pesquisa (Interfarma) stated that merely retaining prescriptions would not address the root causes of the issue, such as the burgeoning black market for these drugs. They noted that between February 2023 and January 2025, approximately 17.83 kilograms of semaglutide were acquired by importers and compounding pharmacies, enough to produce around 4 million irregular pens. Additionally, over 10 kilograms of tirzepatide, the active ingredient in Mounjaro, were registered for import, indicating a substantial underground market.
The Receita Federal, Brazil’s Federal Revenue Service, has also been actively monitoring the situation, having seized over 400 pens in the first two months of 2025 as part of efforts to combat smuggling and unauthorized sales.
As the new regulations take effect, Anvisa's initiative aims to strike a balance between ensuring patient safety and providing access to necessary treatments for diabetes and obesity. The agency's decision reflects a growing recognition of the complexities surrounding obesity treatment and the importance of responsible prescribing practices.
In summary, the mandatory retention of prescriptions for medications like Ozempic and Wegovy represents a significant step in Brazil's efforts to regulate the use of these powerful drugs. As the country grapples with rising obesity rates and the associated health risks, this regulatory change seeks to promote safer, more responsible use of medications designed to aid in weight management.
