With the market for weight-loss pens coming from Paraguay worrying Brazilian health authorities, a test carried out at the Unicamp Information and Toxicological Assistance Center (CIATox) at Unicamp became a weapon for the dissemination of fake news: enthusiasts of the smuggled product say that laboratory analyzes would have proven the equivalence of the Paraguayan tirzepatide with the original version of the drug, Mounjaro.
This statement is false. The National Health Surveillance Agency (Anvisa) had to disclose a denial on Monday (6), reinforcing the risks of using the product, which does not have approval for regular sale in Brazilian territory.
What really happened
Unicamp’s CIATox actually carried out analyzes for check presence of tirzepatide in medicines coming from Paraguay, considering aspects such as the concentration and molecular structure of the active ingredient recognized by Mounjaro.
The tests confirmed that there was a molecule with a molecular structure similar to that of tirzepatide in the samples, but, contrary to what was widespread on the networks, This does not mean that the product is equivalent to Mounjaro.
Anvisa explains: the simple presence of the substance in the bottle does not guarantee any other type of similarity compared to the original product.
CIATox analyzes did not evaluate any safety criteria such as the possible presence of impurities, contaminants, sterility and, especially, bioavailabilityessential information to understand whether one medicine works equivalently to another.
Removing impurities from the substance, in fact, is one of the most complex procedures involving this type of product and, therefore, difficult to reproduce among small pharmaceutical companies.
Why the Paraguayan version should not be used
Due to the issues highlighted above, tirzepatide from Paraguay remains without approval for use in Brazil.
The medicine would need to be subjected to clinical trials capable of proving its efficacy and safety, within the criteria established by Anvisa, and none of that happened.
When using a medicine that has not been approved by Brazilian health authorities nor follows the quality standards established by national legislation, the patient is subject to unforeseen contamination.
Furthermore, when you believe that a medicine is equivalent even without having proof of this, you may end up following a treatment with wrong dosageswhich may be harmless or excessive for your situation.
This may aggravate the condition being treated or promote even more severe side effects than those already known for the original product.
What is the regulatory situation for tirzepatide in Brazil?
Contrary to what happens with other active ingredients, such as semaglutide, which have already had their patent broken, tirzepatide is still a molecule that belongs exclusively to the pharmaceutical company that manufactured it. In Brazil, the only commercial product regularly sold with this active ingredient is Mounjaro, from Eli Lilly.
Furthermore, it is also possible to purchase manipulated versions of tirzepatide, which have generated a lot of controversy in medical entities – organizations such as the Brazilian Society of Endocrinology and Metabology (SBEM), for example, contraindicate its use. Subjected to inspection less rigidmanipulations may also contain impurities, with an even greater risk due to the variety of places capable of producing it.
In any scenario, manipulations should only be carried out individually, in specific situations. However, many companies have exploited legal loopholes to produce irregularly on a large scale, something that authorities have been trying to curb.
