Anvisa (National Health Surveillance Agency) determined this Thursday (23) the ban and recall of batches of drugs containing the active ingredient losartan. The measure was taken due to the presence of the azido impurity in concentration above the acceptable safety limit.
But people using the drug should not stop treatment. According to Anvisa, losartan is the antihypertensive drug and one of the most used drugs for heart failure in Brazil, in treatments that require constant monitoring, and any change can compromise the patient’s health.
As for azide, Anvisa says that they are “substances that may arise during the manufacturing process of the active pharmaceutical ingredient and that have mutagenic potential”. The agency points out, however, that the measure is preventive and was adopted after the evolution of knowledge about impurities, to remove batches with azide from circulation.
Check out questions and answers prepared by Anvisa:
Should I continue taking my losartan?
Yup. Patients using losartan should continue to use their drug, even if they are using one of the affected batches.
Hypertension and heart failure require constant monitoring and any change in treatment should only be made by the doctor accompanying the patient. Failure to take the drug can bring health risks.
I am using medication from the affected batches. What should I do?
If you have it at home or are using one of the banned lots, you should continue the treatment or talk to your doctor, in case of doubt or need for guidance.
It is also possible to contact the laboratory’s SAC (Customer Service) to inquire about exchanging the drug for one from a batch that has not been affected. The channels to contact the companies are available on the packaging and package insert of the medicines.
Why were the recall and interdiction determined?
The measure is preventive, adopted after new discoveries about azide impurities from the analysis of products available on the market. The tests were carried out by the manufacturers of the drug in Brazil, as determined by Anvisa.
What is the deadline for pharmaceutical companies to collect the products?
The maximum regulatory period to complete the collection of these products is up to 120 days, counted from this Thursday (23).
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