This last Thursday (23), the National Agency for Health Surveillance (Anvisa) ordered the recall of Losartana from pharmacies across the country. According to the agency, some batches of the drug for high blood pressure had the presence of “azido” above the acceptable safety limit, which makes them unclean. Still, the agency does not recommend that treatments are stopped even if they are using the affected batches.
Read more: Two drugs have batches collected by Anvisa
In fact, this is not the first time that medicines are collected by the organ this month, as they have already ordered the return of some batches of Zinnat 250mg and Cefagel, two medicines used to treat ear and throat infections. In addition, in September 2021, Anvisa had already disclosed the voluntary collection of Losartana, which were carried out by the companies themselves.
Why were the medicines withdrawn?
First of all, it is important to understand that Losartan is one of the most used drugs 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 medicines can be guaranteed for the Brazilian population.
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 of the shelves (23/06/2022).