Anvisa revokes withdrawal of antihypertensive drug with losartan

More than two weeks after determining the ban and recall of batches of drugs containing the active ingredient losartan, from several manufacturers, Anvisa (National Health Surveillance Agency) announced on Tuesday (12) the revocation of this decision.

The measure had been taken due to the presence of the azido impurity in concentration above the acceptable safety limit. However, last Thursday (7), Anvisa received a study carried out by the European Medicines Agency (EMA) indicating that the degree of impurity of azido is lower than imagined.

“Evidence has shown, from new tests carried out, that the ‘azido’ impurity does not have the toxicity initially identified. Thus, with the new data presented, the safety limits were recalculated, indicating that the drug lots that were recalled or interdicted do not exceed safety limits”, says the Anvisa statement.

According to the agency, the azido impurity is a substance that can arise during the manufacturing process of the active pharmaceutical ingredient losartan. Initially, this impurity was considered to have mutagenic potential, that is, as a possible cause of alterations capable of causing damage to human cells. However, in the face of additional studies performed, the impurity was reclassified to “non-mutagenic”.

Anvisa’s resolution will be published in the Official Gazette this Wednesday (13), confirming the revocation of the previous decision.

“Toxicology, like other areas of scientific knowledge, is constantly and rapidly improving. Thus, the agency remains attentive to scientific advances, and remains committed to promoting and protecting the health of the Brazilian population, always based on sanitary risk and based on available scientific data”, says the note from Anvisa, adding: “Thus, it is reaffirmed that medicines containing losartan are safe and that patients who make use of these medicines should continue using them normally”.