This past Thursday (23), the National Agency for Health Surveillance (Anvisa) ordered the recall of Losartan from pharmacies across the country. According to the agency, some batches of the medicine for high blood pressure had the presence of “azido” above the acceptable safety limit, which makes them impure. Still, the agency does not recommend that treatments are stopped, even if they are using the affected batches.
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By the way, this is not the first time that medicines have been collected by the agency this month, since they have already ordered the return. of some batches of Zinnat 250mg and Cefagel, two drugs used to treat ear infections and throat. Furthermore, in September 2021, Anvisa had already disclosed the voluntary collection of Losartana, which were carried out by the companies themselves.
Why were the drugs recalled?
First of all, it is important to understand that Losartan is one of the most used medicines in the country to combat high blood pressure. Because of this, an assessment was made of the impact on the Brazilian market and the need for continuity of antihypertensive treatments. In this case, although continuity of treatment is recommended, the measure is preventive, so that a certain quality of medication for the Brazilian population can be guaranteed.
Even so, it was only possible to detect the impurities through new analysis techniques, where it was possible to identify the Azido. This substance can arise during the manufacturing process of active pharmaceutical ingredients and has a mutagenic potential, which can cause changes in the DNA of a cell. Recently, these assessments were made by the manufacturers themselves as determined by the agency.
According to the agency, the maximum regulatory period for all products to be collected is up to one hundred and twenty days, counting from the last date of publication of the resolution that determined the removal from the shelves (23/06/2022).
