The National Health Surveillance Agency (Anvisa) determined this Thursday (23) the interdiction and recall of batches of medicines containing Losartan. It was found that the “azido” impurity is present in a concentration above the “acceptable safety limit” in the drugs.
Losartan is one of the most used drugs against hypertension and heart failure in Brazil. The preventive measure, however, does not mean that patients should discontinue treatment.
>>> Check the complete list of lots that will be collected.
According to Anvisa, the maximum period for the collection of batches to be completed is up to 120 days from the date of publication of the agency’s resolution (23/06/2022).
What to do if you have an affected lot at home?
Treatment must continue but it is necessary to talk to your doctor in case of doubts or future directions.
“Hypertension and heart failure require constant monitoring and any change in treatment should be made only by the doctor who accompanies the patient. Failing to take the drug can bring risks to the patient’s health”, warns the agency.
Anvisa points out that it is still necessary contact the Consumer Service (SAC) of the drug laboratory, to inquire about the batch exchange.
The means of contacting the companies are available on the packaging and package insert of the products.
What are azide impurities?
They are substances that arise during the manufacturing process of the active pharmaceutical ingredient. They have mutagenic potential.
Why did Anvisa collect the lots?
It is a preventive measure, performed after carrying out product analyzes in the Brazilian market. Manufacturers were notified by order of Anvisa.
What was there?
The first hint of azide in losartan was in September 2021. Since then, the agency has adopted measures to ensure quality standards. Laboratories have been notified.
“Given the results received, several aspects were evaluated, including the safety of the product and the impact of a possible shortage of this product on the market, considering that losartan is the antihypertensive and one of the most used medications for heart failure in Brazil” , explained to Anvisa.