The National Health Surveillance Agency (Anvisa) will publish resolutions to revoke the recall, interdiction and ban on the marketing of batches of drugs containing the active ingredient losartan, an antihypertensive drug and one of the most used heart failure drugs in Brazil. 
The decision takes place after receiving new scientific data regarding the impurity detected in the active ingredient of the substance. Lots of losartan had been collected between September and October of last year, after finding the presence of an azide-type impurity in the product. In June of that year, another determination by Anvisa returned to collect the medicine from the shelves
“Evidence has shown, from new tests, 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 batches of the drug that were recalled or interdicted did not exceed safety limits,” the agency said.
Also according to Anvisa, the azido impurity 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. In view of additional studies performed, the impurity was reclassified to “non-mutagenic”.
The documents containing the new scientific data were proactively requested by Anvisa and received within the scope of the confidentiality agreement signed with the European Medicines Agency (EMA), after disclosure by the Coordination Group for Mutual Recognition and Decentralized procedures – human (CMDh), a body linked to the EMA, of new information on the azido impurity in losartan.
