Anvisa (National Health Surveillance Agency) determined this Thursday (23) the ban and recall of batches of medicines containing the active ingredient losartan, which is an antihypertensive and one of the most used heart failure medicines in Brazil. . According to the agency, the decision was made due to the presence of the azide impurity in 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.
Click here to consult the list of batches to be collected.
Click here to consult the list of lots that have been banned.
The Anvisa Pharmaceutical Market Statistical Yearbook shows that losartan potassium was, in 2019, the second most commercialized active ingredient in the country, behind only sodium chloride, used as a decongestant, as a vehicle for various injectable drugs or for cleaning wounds, among other functions.
Anvisa warns that people who use the drug should not interrupt their treatment. He adds that hypertension and heart failure require constant monitoring and that any change in treatment should only be made by the doctor accompanying the patient. Failure to take the drug can lead to risks of stroke and heart attack, among others.
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 the contaminant in question, explained Anvisa.
Affected lots in use
For people who are using affected batches of the drug, Anvisa’s guidance is to continue treatment and talk to the doctor if there are any questions or need for guidance.
The explanation for this decision is that there is no immediate risk in relation to the use of this medication, because there are no data that indicate an increase in adverse events.
The agency informs that there are other losartans on the market that can replace the withdrawn or interdicted drugs, but the exchange should only be done under medical prescription and when the user already has the new one in hand.
Patients can also contact the SAC (Customer Service) of the manufacturing laboratory to inquire about the exchange of the drug for a batch that has not been affected by the recall or interdiction.
The means of contacting the companies are available on the packaging and on the product leaflet.
Through a note, Anvisa clarified that, since the discovery of the possibility of the presence of azide 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 informed the registration holders of these drugs that it is necessary to present the results of the evaluation on the existence of this impurity in their products.
Losartan is considered a safe and effective drug, so the registrations of these drugs remain valid in Brazil and in several other countries.