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Brazil Tightens Control on GLP-1 Agonist Drugs Amidst Misuse Concerns
Brazilian health authorities are implementing stricter regulations on the sale of GLP-1 agonist drugs like Ozempic, Wegovy, and Saxenda. These medications, intended for diabetes and weight loss, face increased scrutiny due to a rise in thier unapproved use, especially for cosmetic purposes.
The National Health Surveillance Agency (ANVISA) is mandating that prescriptions be retained at the point of sale. While these drugs are already classified as “red stripe” medications requiring a prescription, this rule wasn’t consistently enforced. The new measure, an update to Resolution of the Collegiate Board (RDC) 471/2021, will take effect 60 days after its publication in the Federal Official Gazette.
ANVISA’s decision stems from its pharmacovigilance system, Vigimed, wich tracks adverse drug effects. Data revealed a disproportionately high number of adverse events in Brazil linked to inappropriate use of these medications compared to other countries.
Rising Concerns Over Unprescribed Use
“without continuous medical and nutritionist support, lean mass is irreversibly lost and, after the suspension of medication, this wear and tear acts as a powerful trigger for the rapid weight breach.”
The overuse of “weight loss pens” without medical supervision is raising alarms among health authorities and experts. A study presented to Anvisa by USP researcher Thamires capello indicated that 45% of users take these drugs without a prescription, and 73% of those recieve no guidance from healthcare professionals. Over half of the users consume the medicine solely for weight loss purposes.
Endocrinologist Cristina Schreiber, director of the department of Endocrinology of Sport and Exercise of the Brazilian Society of Endocrinology and Metabology (SBEM), emphasizes the risks: “With medical follow -up, the lack of appetite is monitored, as is the dietary standard, preventing the patient from stop eating properly, for example.” She warns that improper use can lead to malnutrition, muscle loss, and hair loss.
Nutrologist Noé Alvarenga highlights the “accordion effect,” where rapid weight regain occurs after discontinuing the drug without proper support.
The surge in off-label use is also impacting patients with type 2 diabetes who rely on these medications.Endocrinologist and nutritionist Samara Rodrigues notes a 41% increase in prescriptions for weight loss drugs by 2022 compared to the previous year.She cautions that many users might potentially be unaware of potential side effects like gastrointestinal issues, increased pancreatitis risk, and thyroid problems.
International data supports these concerns.A study in Diabetes Care revealed that approximately 30% of Ozempic prescriptions worldwide in 2021 were for individuals
