Anvisa determines withdrawal of losartan-based medicines

The National Health Surveillance Agency (Anvisa) determined, today (23), the ban and recall of batches of medicines containing the active ingredient losartan, which is an antihypertensive and one of the most used medicines for heart failure in Brazil. According to the agency, the decision was made due to the presence of the “azido” impurity in a concentration above the acceptable safety limit.

The maximum regulatory deadline for completing the collection of products from pharmacies is up to 120 days, counting from today, the date of publication of the resolution, for which Anvisa evaluated the impact on the Brazilian market and the need for continuity of treatments.

Anvisa advises that people who use the drug should not interrupt their treatment. He added that hypertension and heart failure require constant monitoring and any change in treatment should only be made by the doctor accompanying the patient. Not taking the medicine can bring health risks.”

The preventive measure was adopted after the evolution of knowledge about impurities and it serves to adapt the products used in Brazil to the technical limits foreseen for the presence of this contaminant, explained Anvisa.

Affected lots in use

In cases of people who are using affected batches of the drug, Anvisa’s guidance is to continue the treatment and talk to the doctor in case of doubt or need for guidance. Patients can also contact the laboratory’s Customer Service (SAC) to find out about exchanging the drug for a batch that has not been affected by recall or interdiction. The means of contacting the companies are available on the packaging and package insert of the products.

Through a note, Anvisa clarified that, since the discovery of the possibility of the presence of “azido” in losartan, in September 2021, it has been adopting measures to ensure that the medicines available to the Brazilian population are within quality standards.

Anvisa notified the registration holders of these drugs to present the results of the evaluation on the existence of this impurity in their products.

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