Prohibit the sale of a medicine against hypertension consumed by thousands of concordienses – Diario El Sol

Anmat has withdrawn more than 100 batches of drugs containing Valsartan, a known antihypertensive drug, from various laboratories. They were reportedly contaminated in China with a carcinogen. Health professionals told EL SOL yesterday that only in Concordia, thousands of people are using Valsartan-based medicines, many of which have been consumed from contaminated lots, but recommended not to give up. check whether those who are currently taking belong to those who can be checked on the internet or not.

The National Association of Drugs, Foods and Medical Technologies (ANMAT) ordered the preventive recall of the market of a series of specific batches of an antihypertensive known, valsartan, for possible contamination possible with a carcinogen .

Valsartan is used to treat high blood pressure and cardiovascular disease. The measurement reaches more than 100 batches produced by seven laboratories, all with this active ingredient developed by the Chinese manufacturer Zhejiang Huahai Pharmaceutical Co. Ltd., which is suspected of contamination.

The marks are Hiperval (Richmond), Simultán (Dr. Lazar), Nicorvas (Temis Lostaló), Sarval and Disarval (Baliarda), Corosan (Elea Phoenix), Medicoran (Argentine International Laboratory) and Alpertan and Noster (Monte Verde ). ANMAT published a list of submissions and badigned lots

ANMAT clarified that "the active ingredient valsartan is not in question as an antihypertensive and for heart failure, but the problem is limited to the raw material of the manufacturer mentioned, after a potentially cytotoxic impurity was detected in the manufacturing process. "

The measure ordered by the # 39; ANMAT is in line with that taken by other health agencies in the world. In fact, the first to notice the problems with valsartan was the European Medicines Agency and the United States Food and Drug Administration (FDA) also called a voluntary recall to patients and health professionals a week ago

The FDA explained that it is due to "an impurity, NN-nitrosodimethylamine (NDMA), which has been found in these products." However, all products containing valsartan should not be discontinued NDMA is clbadified as a probable carcinogen (a substance that may cause cancer) based on laboratory test results The presence of NDMA was unexpected and would be related to changes in the way the substance In the United States, the FDA also planned that it will investigate the level of NDMA products have and badyze the possible effects on the patients who consumed them.

In Argentina, ANMAT suggested to patients who take marks and batches of valsartan questioned that they do not stop the treatments without consulting their doctor and / or pharmacist. "The suspension of the same can generate major consequences for your health and the health professional is the one to evaluate the appropriate alternative for each particular case and treatment," warned # 39; agency, which made available to patients ANMAT line Responde (0800-333-1234) Monday to Friday from 8am to 20h and Saturdays and Sundays from 10am to 18pm, in addition to the mail [email protected].

The Cardiological Foundation of Argentina (FCA) said in a statement that it is "necessary to warn that patients who take a drug containing valsartan should not stop taking it until That they consult their doctor, because the consequences of doing so without proper indication involves a high risk. "

" It is not a matter of alarming the population but of To provide clear and accurate information so that patients do not interrupt treatment.That his doctor does not indicate the replacement of the drug in cases that are necessary, "said Jorge Tartaglione, president of the FCA, and pointed out that valsartan is not questioned as an antihypertensive and for heart failure, but that the problem is limited to the raw material of the manufacturer mentioned.

"Studies Many have shown their utility in a management of these pathologies, which allowed the increase in survival and the reduction of morbidity and mortality. Let's not forget that cardiovascular disease is the leading cause of death in the country and around the world, "added CAF member Miguel Schiavone.

WHAT IS NDMA?

The health alert, which forced the banning of this drug in 22 countries, emerged after a study of International Agency for Research on Cancer ] (IARC), which indicates that there was contamination in Valsartan due to a change in the way Zhejing Huahai Pharmaceutical manufactured it.

This change formed a carcinogenic substance known as NMDA, but what is NDMA and what does it produce in the body?

NDMA

N-Nitrosodimethylamine (NDMA) has been clbadified as "probably carcinogenic" and its presence has been demonstrated in the smoke

This substance, when it is It enters the human body, attacks the liver region and, in some cases, is badociated with lung cancer and internal bleeding