It was recently disclosed that the National Health Surveillance Agency (Anvisa) determined the collection of lots of the drug Losartana. The drug is the most used in Brazil by patients with heart failure. See which lots and how to make the switch.
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According to the agency, the measure is preventive. “Azide”, a type of impurity, was identified in amounts above the limit considered safe in the medicine. With the determination, the lots must be removed from pharmacies within 120 days.
Despite the withdrawal of Losartana, Anvisa advised that patients who use the drug do not interrupt the treatment. The agency also reinforced that, as it is a drug against hypertension and heart failure, only a doctor can change the type of treatment.
For this reason, Anvisa considered the maximum period of 120 days – from the publication of the resolution on June 23 – for the collection.
According to them, the collection of lots of Losartana is only to adapt the medicine used in Brazil to the technical limits of the contaminant. “Azido impurities are substances that can arise during the manufacturing process of the active pharmaceutical ingredient and that have mutagenic potential”, clarifies the agency.
The agency’s guidance is for patients to contact the Customer Service (SAC) of the laboratory that produces the drug and to find out how to guarantee the exchange for a new batch that has not been withdrawn of circulation for them. The information is on the packaging and package insert of the medicines.
Also in a statement, Anvisa said that since the discovery of the possibility of the presence of azide in Losartana, in September 2021, they are adopting, together with the producing companies, some measures to ensure that the medicines available to the Brazilian population are within the standards Of Quality.
To check the complete list of all batches that must be collected, patients can access Anvisa’s official page through the gov.br portal.