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Ozempic: experts warn against free use of diabetes medication.

This week, Dr.Andrea Pereira spoke to Correio Braziliense.

See the report below.

Indicated for treating diabetes, the medication has been widely used for weight loss. Experts warn of the danger of self-medication and defend public policies for the overweight population.

The fame of injectable weight loss medications has grown markedly in recent years. Ozempic,dicated for the treatment of type 2 diabetes, became a real rage. According to the Consulta Remédios platform, searches for the medicine increased by 91% in the first half of 2023. With more than half of the Brazilian population (55.4%) overweight and almost 20% obese, experts approve new treatment options, but we emphasize that use should only be done under medical advice.

Although Ozempic has been approved for the treatment of diabetes,expectedlled “off-label” use is common to combat excess weight. However, the endocrinologist and president of the Brazilian Society of Endocrinology and Metabology (SBEM), Paulo Miranda, warns that the medication is not recommended for specific aesthetics.

"Although Ozempic is not registered on the leaflet for the treatment of obesity, we already have data on its safety and effectiveness for this purpose. It follows the principles of science and should be applied for what has been trained and not for the desired weight loss program," says Miranda.

The president of Anvisa, Antônio Barra Torres, also highlights that the approval and analysis of all medicines is based on what the leaflet contemplates. "We have no action on off-label use, but that does not mean that we are not attentive and monitoring these cases. It is a new medicine that will still have an observation, and monitoring curve by the agency, and we will analyze all adverse effects", he assured.

Furthermore, the National Health Surveillance Agency (Anvisa) approved, this year, two more injectable medicines, Mounjaro and Wegovy, which are not yet on sale in the country. Both have the same active ingredient as Ozempic, the substance semaglutide, but they were studied for the treatment of specific populations and pathologies and their presentations, doses, and approvals are different. Studies show that patients lost up to 17% of their weight with Wegovy, in addition to showing improvements in metabolic parameters, such as a reduction in triglyceride, cholesterol, and blood glucose levels.

The pharmaceutical company responsible for manufacturing these medicines, Novo Nordisk, does not endorse or support the promotion of off-label information, and Ozempic does not have an indication approved by national and international regulatory agencies for the treatment of obesity.

Excessive doses

Ozempic consists of a weekly injection pen. The dose releases a substance that, in addition to stimulating insulin production and reducing blood glucose levels, promotes satiety. Therefore, those who use the medicine feel less hungry and lose weight. However, use must be accompanied by a change in habits, such as diet and physical activity.

And there are other precautions. "Regardless of the dose, it should only be prescribed once a week at most. I've seen nonsense with daily use, and this is extremely dangerous", warns the doctor and president of the Brazilian Diabetes Society (SBD), Levimar Araújo.

Another issue is that Ozempic is sold without prescription retention; that is, although it is mandatory to present it, the pharmacy does not need to keep it. For Miranda, this makes purchasing easier for people who do not have a medical recommendation. "This leads to self-medication, which is not recommended," warns Araújo.

Furthermore, anyone who uses the medicine should also be aware of counterfeits. Last Friday, Anvisa published an alert about counterfeit batches following a notification from the company responsible, Novo Nordisk. The pharmaceutical company denounced batch LP6F832 as false, which would indicate validity until 2025. The agency advises that they should only be purchased in regulated establishments, inside the packaging, and with an invoice.

The main adverse effects of Ozempic are related to the gastrointestinal tract, such as nausea, vomiting, and a feeling of a full stomach, other symptoms such as headache and a slight increase in heart rate may also occur. "The medicine cannot be used by those who have more serious intestinal problems. Therefore, it is essential to consult a specialist doctor", highlights Araújo.

The World Obesity Atlas 2023 estimates that 41% of the Brazilian adult population will be obese by 2035. Currently, the SUS does not provide any medication against the disease. Andrea Pereira, Clinical Nutrition Physician and co-founder of the NGO Obesidade Brasil, says that the lack of medication leads to an increase in the queue for bariatric surgeries, as changing lifestyle is often not enough.

"Today, we have very effective medications for controlling obesity, but they are restricted to the upper class. This needs to be discussed further by the SUS(Public Health System in Brazil) because obesity is a chronic disease. The medications are part of the treatment," he says.



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