Patients with heart problems and hypertension are concerned about the voluntary recall by pharmaceutical companies Sanofi Medley and Sandoz of batches of the generic drug losartan.
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The measure was taken preventively, between September and October of last year, after “azido” type impurities were found in the product. The information is from Agência Brasil.
Anvisa’s guidance is that losartan users do not stop using the product on their own. “Losartan belongs to the class known as “sartanas”, which are safe and effective drugs in the control of the treatment of hypertension and heart failure, significantly reducing the risk of stroke and heart attack. Discontinuing treatment with losartan without the correct medical advice can lead to serious problems, such as episodes of hypertension,” the agency warned.
Another recommendation by Anvisa is that patients who have any questions about their current treatment should talk to their doctor or pharmacist. Any suspected adverse events must be reported to Anvisa and informed to the responsible physician. The notification can be sent directly to the agency via the link.
The most recent recalls of some batches of the drug losartan took place in September and October 2021 and the manufacturers have now completed this work. In addition to this measure, from the publication of Anvisa’s resolutions that suspended the sale, no batch of these products can be offered for sale.
Impurity can be a by-product
Regarding the presence of the “azido” impurity found in medications, Anvisa explained that it may be the result of the active pharmaceutical ingredient manufacturing process, that is, a by-product of chemical interactions that take place during the production of the substance.
The substances have been identified by the manufacturers’ own quality control, which follow Anvisa’s regulations that determine the control over impurities in medicines.
This process is continuous within the company’s routine, in order to ensure that the products sold are suitable for consumption.
Regarding possible risks for patients who make continuous use of these drugs, Anvisa stressed that the withdrawal is a precautionary measure. “There are no data to suggest that the product containing the impurity caused a change in the frequency or nature of adverse events related to cancers, congenital anomalies or fertility disorders. Thus, there is no immediate risk in relation to the use of this drug”, said Anvisa in a note.
The agency will continue to monitor the presence of impurities in medicines and will take all necessary measures to protect the health of the population. Healthcare professionals and patients can report suspected adverse drug events to the agency via VigiMed.
Do I have the medicine at home?
US links Below you can check the products and batches, according to the manufacturer:
1) Losartan potassium – Sanofi Medley
2) Losartan potassium + hydrochlorothiazide – Sanofi Medley
3) Lorsacor and losartan potassium – Sandoz
The complete list of all drugs with withdrawal or suspension determination can be consulted here at link.
about the case
After receiving international alerts related to the presence of the impurity known as “azido” (LADX) in the active pharmaceutical ingredient losartan potassium, as well as in other drugs of the sartan class, Anvisa recently issued a statement on the subject.
In September last year, the European Directorate for the Quality of Medicines & HealthCare – EDQM (European authority) published information about a recent investigation that had shown that this impurity has mutagenic potential (which can cause mutations and change the genetic code of a individual). This impurity tested positive in a bacterial mutagenicity test (Ames).
After that, alerts were issued and recall actions were taken by various regulatory authorities, from EDQM to Health Canada (Canada agency), Medicines and Healthcare Products Regulatory Agency – MHRA (UK agency), Therapeutic Goods Administration – TGA (Australian agency). ), Health Sciences Authority – HSA (Singapore agency) and Swissmedic (Swiss agency).
Based on information from the EDQM and, later, on the results of analyzes of this impurity carried out by manufacturers of IFA losartan, and even though they did not receive reports of adverse events that could be related to this finding, two companies that own drugs containing losartan informed the Anvisa, in a preventive way, the voluntary collection of its products.