O recentity lot collectionMedicine generic losartanby the presence of impurities ofAzide This is preventive action that has been taken since the discovery of the possible presence of these contaminants in the drugs of the “sartanes”.
According to the regulations of a visaOthe manufacturers they must guarantee the absence of impurities in the medicines and set up quality control and monitoring systems.
In the last days, the Agencyreceived a series of questions about the use of these drugs, given the recent voluntary collections carried out by pharmaceutical companies.
The direction of a visa This is that users of losartan no interrupta m the use of product all alone.
THE losartan belongs to class known as “sartanes”, which are medications safe and effective in controlling the treatment of hypertension and heart failure, significantly reducing the risk of stroke and heart attack.
Interruption of treatment with the losartanwithout the adviceto the good doctor can lead to serious problemsPhone in the form of episodes of hypertension.
Understand the case and what to do
What are the bundlesMedicine losartan collected?
The latest collections from a few batches DMedicine losartantook place in September and October 2021. In the links below, you can check the products and the a lot, according to maker:
3) Lorsacor and meosartanepotassium – Sandoz
These lots are still in the Marketplace ?
You fanjokers already concludedgo the meeting. Beyond Starting from, to suspendRAM commercialization, nothing group this sides products can be put up for sale.
What should the patient do do?
Patients should not discontinue treatment unless they have been informed fur your doctor. It is also recommended that patients who have questions about their current treatment speak to their doctor or pharmacist.
Any suspected adverse eventsS.O.S. this must be notifyeach the a visa and informada To the doctor responsible. Notification can be sent directly the Agency, fur link https://primaryreporting.who-umc.org/BR
drugs withwhile having losartanthe were collectionyou?
withdrawals had finished voluntarily by certain manufacturers and affect only batches dyou products in which quality control has identified the presence of impurity Azide.
where do you come fromandthese impurities?
the presence of impurity Azidemay be the result of the manufacturing process of the active pharmaceutical ingredient, i.e. a by-product of chemical interactions that take place during the production of the drug. substance.
The substances were identified by the quality control of thethe manufacturers, that follow the rules of a visa who determines the control on impurities in drugs. This process is as part of the company’s routine, in order to ensure that the products sold are fit for consumption.
What is the risk for patients using continuation of these drugs?
Withdrawal is a precautionary measure. There is no data to suggest that the product containing the impurity caused a change in the frequency or nature of adverse events related to cancers, birth defects or fertility disorders.
There is therefore no immediate risk associated with the use ofthis meDIvsis lying.
THE a visa will continue to monitordetermine the presence of impurities in medicines and will take all necessary measures topopulation health.
It is important to emphasize that healthcare professionals and patientscan communicate with Agency suspected adverse drug events.
Notify by VigiMed.