The American association of diabetes and Brazilian entities underlines that the manipulated formulas of trafficlutida and tizerpatida, the active ingredients of the drugs used to treat diabetes and obesity, can be health risks; In Brazil, these products do not have the approval of Anvisa
The American Diabetes Association (Ada) published last December a Document by supporting the use of manipulated versions of semaglutado and thypatide medicines. These drugs are approved by the Food and Drug Administration (FDA), the United States regulatory agency, for treatment diabetes Type 2, reduce cardiovascular risks and help in weight control. According to Ada, manipulated versions can lead to products with inaccurate concentrations or impurities and do not offer the guarantee of the origin and quality of the inputs, which could compromise the effectiveness and safety of the treatment.
THE semaglutado (Sold by the new Danish pharmacist Nordisk with commercial names Ozempic AND Wegovy) and the tirzepatida (produced by the United States Eli Lilly as Mounjaro) are biological medicines. The semaglutido has its own substances of active ingredient agonists of the GLP-1 hormone, while Tirzepatida is a double agonist and also stimulates a hormone called the investigating judge. As a result, they reduce appetite and response to the action of insulin.
“SBD complies with the recent positioning of the ADA and does not indicate the use of traffic lights manipulated in any situation. The question can temporarily exceed the offer, with consequent intermittent absence and, in these cases, our recommendation is the exchange for a Another drugs approved by Anvisa, such as Liraglutide “, leads the endocrinologist Marcio Mancini, coordinator of the Department of Obesity and SBD metabolic syndrome.
According to Mancini, the manipulated traffic light is not identical to the FDA and the traffic light approved by Anvisa: the drug issued by the regulatory agencies is made by a biological molecule; The manipulated are synthetic and contain salts (such as traffic lights or sodium acetate traffic lights) or other substances in the formulation, such as vitamins B12 and B6. “The impact of these changes on pharmacokinetics, pharmacodynamics, effectiveness and safety are unknown. The managed compounds are not subject to bioequivalence tests as required for medicines,” says SBD expert.
In addition, manipulated products can have variable concentrations and be fired in various shapes, such as ampoules, multidosis and syringes previously filled. “The FDA has documented doses of doses of five to 20 times bigger than the desired, due to the lack of experience of the car individual -set, with serious side effects, including syncope, dehydration and acute pancreatitis, with the need to hospitalization, “says Mancini, says. “It is important to note that the harmful consequences of the widespread use of the analogues manipulated LPG-1 are starting to be documented. The real area of the problem is probably much greater.”
Sbem and Abese are also found against the use of manipulated versions. “We do not indicate in any situation. Ozepic and Mounjaro are organic drugs and what has been manipulated is a synthetic product that is not yet approved by Anvisa and, therefore, we do not know quality, safety or efficacy”, comments Cintia searched, member of the department of obesity of Sbem and president of the deliberative council of Abeseo.
The endocrinologist Paulo Rosenbaum, from the Israelite Albert Einstein hospital, also recommends the use of manipulated versions of these drugs and underlines that they have revolutionized the treatment of diabetes e obesityWith very consistent results. “These medicines have shown that, in addition to weight loss, they have a metabolic and cardiovascular benefit, reducing the risk of infarctionescape, renal failure and even cases of Cancer“, He underlines.
The problem, in the Rosenbaum evaluation, is the high cost of these drugs and the need for long -term use, which would be to induce many people to seek more convenient ways to acquire them. “With the Internet and social media, many people find other ways to buy these cheaper, important or sending of manipulations without any control. It has become a trade, we see many cases of falsification”, warns the endocrinologist.
Another point of attention are the cases of those who use these drugs for aesthetic purposes, not for the treatment of obesity, with follow -up. “Turk and then I receive messages from people asking for prescription for the purchase of income abroad, has already happened to come with a tinzepatida glass bottle and ask for a guide on how to use it. But who certifies the quality of what is in This bottle? ” .
For the endocrinologist Clayton Macedo of the Israelite Albert Einstein hospital and Sbem director, these organic drugs are delicate and need a series of care during their production. “One of the main problems of the analogues manipulated LPG-1 is that, since they are injectable drugs, the entire production process should follow rigorous standards that guarantee a completely sterile environment and components meet the highest standards of quality and purity. Failure to this in this Process can compromise the safety and effectiveness of the treatment, “says Macedo.
How do manipulation pharmacies work?
According to Anvisa, the manipulation of medicines is allowed by Brazilian law, provided that it complies with the resolution number 67/2007. The standard states that master pharmacies “can transform an exceptional pharmaceutical specialty when there is unavailability of the raw material on the market and absence of specialties in dose and concentration and/or pharmaceutical form compatible with the patient’s clinical conditions, in order to adapt it to Condition prescription. “
That is, manipulation pharmacies work differently from a conventional pharmaceutical sector: they cannot produce large -scale drugs; They can only manipulate drug drugs other than drugs available in pharmacies and aim to meet the patient’s individual needs. Even every manipulation of medicine needs the prescription of a doctor.
“There are drugs recorded with Anvisa and available on the internal market with the semaglutido active ingredients (active ingredient of Ozempic/Wegovy) and Thyepatida (active ingredient of Mounjaro), which does not justify the manipulation of the pharmacy in the same doses, concentration or pharmaceutical approved form .
The health agency also clarified that the import, manipulation and marketing of synthetic active pharmaceutical inputs (IFAS) are not authorized, “because their safety and effectiveness has not yet been evaluated”. The acronym refers to molecules that represent the active ingredient of a medicine. Only IFA biological semaglutids and tirzepatida have been approved so far by Anvisa.
What pharmacists say
In a declaration, Novo Nordisk reported that “the active traffic ingredient has not been developed anywhere in the world, for use injectable in ampoules, oral capsules, absorbable pellets, tapes or chips. New Nordisk is not aware of the origin of the materials -prime and the form of production of these products.
Eli Lilly claims to be worried about the proliferation of online sales and social media posts that involve counterfeit versions of Tirzepatitada that can endanger the health of patients. “Lilly’s Tirzepatida is the only one approved by the health authorities, the pharmacist is the only legal supplier of the molecule and does not provide any ingredient principle or active for the management of pharmacies or any other company. Lilly in Brazil and there is not yet no prediction for the arrival of the product in the national market.
The National Association of Magistral Pharmacists (ANFARMAG) was sought by the Einstein agency, but reported that the members of the Board of Directors were in return and did not respond until the publication of this report.
Source: Terra
Ben Stock is a lifestyle journalist and author at Gossipify. He writes about topics such as health, wellness, travel, food and home decor. He provides practical advice and inspiration to improve well-being, keeps readers up to date with latest lifestyle news and trends, known for his engaging writing style, in-depth analysis and unique perspectives.
