Posted 06/23/2022 13:34
(Credit: Marcelo Camarago / Brazil Agency)
The National Health Surveillance Agency (Anvisa) today (23) vowed to ban batches of drugs containing the active ingredient Lucartan, an anti-hypertension and one of the most common forms of heart failure in Brazil. Is one of the medicines used. According to the agency, the decision was made due to the presence of “azido” impurity in an acceptable concentration of acceptable safety limits.
The maximum regulatory deadline for collecting products from pharmacies is 120 days, counting from today, the date of publication of the resolution, for which Anvisa reviewed the impact on the Brazilian market and the need for continuity of treatment.
Anvisa advises that people who use the drug should not interrupt their treatment. He added that high blood pressure and heart failure require constant monitoring and that any change in treatment should be made only by the doctor accompanying the patient. Not taking the medicine can endanger your health. ”
Invesa explained that the precautionary measure was adopted after the evolution of knowledge about impurities and that it works to bring the products used in Brazil into line with the technical limits predicted for the presence of this contamination.
Many were affected by the use.
In the case of people who are using infected batches of medicine, Anvisa is instructed to continue treatment and talk to a doctor if in doubt or in need of guidance. Patients can also contact the Laboratory Customer Service (SAC) to find out about a drug exchange for a batch that has not been affected by withdrawal or withholding. Means of contacting companies are available on product packaging and package insertion.
In a note, Invisa clarified that, since the discovery of the possibility of the presence of “Azido” in Lasarten in September 2021, it has been taking steps to ensure that the medicines available to the Brazilian population are standardized. Be within the standard.
Anvisa informed the registration holders of these drugs to present the results of the review of the presence of this contamination in their products.