Mandatory prescription: experts defend measure for purchase of Ozempic and similar products

The determination by Anvisa (National Health Surveillance Agency) that establishes the requirement of a medical prescription for the purchase of GLP-1 agonist drugs, such as Mounjaro, Ozempic and Wegovy , comes into effect this Monday, the 23rd.

For doctors interviewed by IstoÉ , the requirement is an effective measure to curb irresponsible consumption and reverse the trivialization of the use of medications, known as “slimming pens” .

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Scenario of excesses

According to Giovana de Paula, a general practitioner at Santa Casa de Misericórdia de Chavantes, the rule approved by Anvisa responds to the “trivialization” of treatment with pens , which are recommended by professionals for treatments against type 2 diabetes, overweight associated with comorbidities and compulsive eating.

For the doctor, “ ease of access, high visibility on social media and the search for quick solutions for weight loss ” contributed to this scenario. “There is a shared responsibility among health professionals, especially when there is a prescription without careful evaluation or due monitoring,” she told IstoÉ .

Nutritionist Fernanda Vasconcelos, founder of the Qualitté Institute, followed the same line. “ The medications were even sold in beauty salons , without the recommendation of professionals. Serious treatments were sold as 'shortcuts' to weight loss,” she said.

According to data released by the newspaper Valor Econômico, Novo Nordisk, responsible for the distribution of medicines such as Ozempic, Wegovy and Saxenda in Brazil, had revenue of R$3.7 billion during 2023 — a growth of 52% compared to the previous year — with pens as its main sources of income.

In a statement published after Anvisa's decision, the company reiterated that the “safety and efficacy” of its products had been proven worldwide . Novo Nordisk said it “shared Anvisa's concerns regarding the irregular use of medications and those not indicated in the package insert”, that patient safety was its main commitment and that it was committed to “awareness campaigns, educational actions [regarding self-medication and off-label use] and reporting cases of counterfeiting” of the pens.

Negative consequences

Four of the 12 prescription drugs are indicated for combating obesity, which is why they have become popular among consumers as “ slimming pens .” “ The goal is to help with weight loss when traditional measures, such as diet and exercise, have not been sufficient on their own, ” said Giovana de Paula.

With this in mind, Gabriela Cilla, gastrologist and nutritionist at NutriCilla , stated that the rush to make the treatment effective leads people to adopt the pens as their only weight loss resource. For the specialist, excessive use, in addition to being dangerous, “is not necessarily an efficient treatment for weight loss”, as it overshadows the importance of other actions such as dietary reeducation, physical activity and sleep regulation.

Without proper medical supervision and used as an isolated instrument in treatment, medications have been associated with gastrointestinal disorders, nausea, vomiting, diarrhea and constipation . There are also reports of pancreatitis, gallstones and, in some cases, changes in eating and psychological patterns, such as distorted body image or a dysfunctional relationship with food among patients.

“Use without guidance can also lead to loss of lean mass, protein malnutrition and even distortions in the relationship with food,” added Fernanda Vasconcelos. “The treatment of obesity and overweight is multifactorial and must be individualized. There are other oral medications, behavioral therapies, nutritional monitoring, regular physical activity and, in more serious cases, bariatric surgery,” she concluded.

Revenue is a brake mechanism

For the nutritionist, withholding the prescription creates a significant barrier to the use of pens . “Withholding the prescription requires continuous monitoring of patients, which favors a safer and more targeted approach. It discourages self-medication and use without a prescription,” she said.

In practice, consumers and retailers will be subject to the rule that already applies to antibiotics: one copy of the prescription is retained by the pharmacy and sent to the agency for inclusion in the system for monitoring controlled products. This process “allows for better tracking and control by pharmacies and health authorities,” said Giovana de Paula.