Sanofi Medley announced last Monday (7) that the recall of batches of losartan tablets, which has been taking place since February, is voluntary and preventive. The drug is recommended for people with high blood pressure.
The products are:
- losartan potassium + hydrochlorothiazide 50 mg + 12.5 mg
- losartan potassium + hydrochlorothiazide 100 mg + 25 mg
- losartan potassium 50 mg and 100 mg
According to the pharmaceutical company, the withdrawal occurs after mutagenic impurities are found in the medication.
A mutagenic impurity is a chemical that can cause a change in a cell’s DNA, according to the company. These mutations may increase the long-term risk of cancer, but the specific risk of this impurity resulting in cancer in humans is currently unknown.
According to the drugmaker, there is no data to suggest that the batches with the impurity have generated “a change in the frequency or nature of adverse events related to cancers, congenital anomalies or fertility disorders”.
Sanofi Medley warns that abrupt discontinuation of treatment can bring potential risks to patients, and therefore must be accompanied by the treating physician.
“The health risk of abruptly discontinuing these medications without consulting your physicians or without an alternative treatment is greater than the potential risk posed by impurity at low levels,” the company says.
anvisa
The impurities, called nitrosamines, are found in water, smoked and grilled foods, dairy products and vegetables, explains Anvisa (National Health Surveillance Agency).
In 2018, the agency and regulatory bodies in other countries detected the presence of these mutagenic impurities in drugs of the sartan class, such as losartan and valsartan.
The following year, Anvisa determined the collection of 185 batches of medicines in the country.
In 2020, another drug had to be withdrawn because of the same problem in Brazil. At the time, it was necessary to recall Ranitidine, which inhibits the production of acid by the stomach and is normally used in the treatment of gastric ulcers.
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