Batch of Sanofi-Medley and Sandoz drugs, which contain an impurity, were identified late last year.
Although French biopharmaceuticals Sanofi started calling (pull from Drugs about Hypertension With Medley brand losartan in February of this year, The National health monitoring (Anvisa) actually requested product recalls last year.
Anvisa states on its website that users of losartan should not stop using the product on their own. This type of medication is considered safe and effective in treating high blood pressure and heart failure, significantly reducing the risk of stroke and heart attack.
Discontinuing use without medical advice can cause serious problems.
What is too much losartan called?
The recalls that became news recently relate to health watchdog decisions for September and October 2021.
See what they are:
- Losartan Potassium – Registration: 183260155
- Losartan Potassium + Hydrochlorothiazide – Registration: 183260109
- lorsacor – registration: 100470315
- Losartan Potassium + Hydrochlorothiazide – Registration: 100470528
- Losartan Potassium – Registration: 100470542
Are these quantities still available in the market?
Manufacturers have already completed the recall process, according to Anvisa. Additionally, as of the publication of the resolutions halting marketing, no batch of these products can be put up for sale in the market.
What should the patient do?
Patients should not stop treatment with losartan unless advised to do so by their physician. The agency recommends that if medication use is in doubt, speak to a doctor or pharmacist.
If adverse reactions are suspected with the use of the drug, it is necessary to notify Anvisa in the system Vegemed.
Where do losartan impurities come from?
According to Health Watch, the presence of azide may be a result of the manufacturing process of the active pharmaceutical ingredient, that is, a by-product of chemical reactions that occur during the production of losartan.
“The first information, received in the second half of 2021, indicates the possible presence of impurities of the azide group, potentially mutagenic, capable of causing mutations, that is, changing the genetic code of an individual, in some active substances of the “Sartanas” class, as Anvisa says in Location.
Hazardous substances are usually identified by the manufacturer, which must follow health control regulations. This process should be routine in the company, to ensure that the products sold are fit for consumption, the agency warns.
What are the risks of continuous use of the two ministries with impurity?
Withdrawal is a precautionary measure. There are no data to suggest that a product containing impurities has caused a change in the frequency or nature of adverse events related to cancer, birth defects, or fertility disorders.
There are no immediate risks when using losartan, which contains azide.
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