The presence of “impurities” in losartan-based drugs does not mean that the drug is unsafe or that patients must suddenly stop using it. People who have medicines from the affected batches in the recall should maintain the routine of use until they have another medicine to then make the substitution. This is what experts heard by GZH clarified after the National Health Surveillance Agency ( Anvisa ) announced, on Thursday (23), the ban and recall of batches of the drug in which the “azido” impurity was detected in a concentration above the safety limit required by the state agency.
Losartan is one of the most used drugs in the country to treat hypertension and heart failure and is capable of reducing the risk of stroke and heart attack. It is distributed in the Unified Health System (SUS) and can be purchased without a prescription at pharmacies. Anvisa gave 120 days for the collection of batches of products from pharmacies, work that must be done by laboratories Aché, Biolab Sanus, BrainFarma, Cimed, Eurofarma, Geolab, Laboratorio Teuto Brasileiro and Prati, Donaduzzi & Cal.
The federal agency notified the registered holders of these drugs to present the results of the evaluation on the existence of this impurity in the products. In March of this year, pharmaceutical Sanofi Medley announced the recall of three losartan-based drug formulations from the market.
- Advertisement -
Authorities in several countries have also adopted collection actions similar to those in Brazil. Anvisa explained that it has adopted measures to ensure “quality standards” since the discovery of the possibility of the presence of the azido impurity in losartan, in September 2021.
Azide impurity: What is it and should it be avoided?
Azido impurities are substances that may arise during the manufacturing process of the active pharmaceutical ingredient and that have mutagenic potential. Simone Verza, professor and researcher for the Master’s in Toxicology and Toxicological Analysis at Feevale University, explains the result of this in a person’s life:
— When present in medicines or other products, these substances (azido impurities) can cause damage, and mutations, in DNA and, therefore, have the potential to cause cancer in case of prolonged consumption. The use of medicines from the collected batches is oriented (by Anvisa) because the interruption of treatment is more harmful to the patient than the presence of these impurities (in the short term).
According to Vítor Magnus Martins, a cardiologist at the Hospital Moinhos de Vento and the Institute of Cardiology, Anvisa’s measure does not change the fact that the drugs are consolidated and effective in the treatment of hypertension and heart failure. In addition, the professional also understands that people who have medicines from the affected batches in the collection should maintain the routine of use until they have another medicine to replace.
No treatment should be interrupted or modified without prior medical advice. The abrupt suspension would likely bring more risks than benefits. The collection of batches was done in a preventive way, to better clarify the potential risks – explains the cardiologist.
Anvisa reported that patients can contact the Customer Service (SAC) of the laboratory to find out about the exchange of medicine for a batch that has not been affected by the recall or interdiction. The means of contacting the companies are available on the packaging and package insert of the products.