Valsartan: ANMAT withdraws from sale a known drug against hypertension – 20/07/2018

The National Association of Drugs, Food and Medical Technology (ANMAT) ordered yesterday the preventive recall of the market from a series of specific batches of a known antihypertensive drug, valsartan, for a hint of possible contamination by a carcinogen .

Valsartan is a widely used drug for the treatment of high blood pressure and cardiovascular disease. The measurement reaches more than 100 batches produced by seven laboratories, all with this active ingredient prepared by the manufacturer Zhejiang Huahai Pharmaceutical Co. Ltd., China, which is suspected of contamination.

The marks are Hiperval (Richmond), Simultán (Dr. Lazar), Nicorvas (Temis Lostaló), Sarval and Disarval (Baliarda), Corosan (Elea Phoenix), Medicoran (Laboratorio Internacional Argentino) and Alpertan and Noster (Monte Verde). ANMAT has published a list of the presentations and assigned lots.

ANMAT clarified that " the active substance valsartan is not challenged as antihypertensive and for heart failure, but the problem is limited to the raw material of the manufacturer, after that it has been detected in the process of development, a potentially cytotoxic impurity. "

The measure ordered by 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 for a voluntary recall of patients and professionals from the health A week ago

The FDA explained that it is due to "an impurity, NN-nitrosodimethylamine (NDMA), which was found in these products In any case, all products containing valsartan should not be deleted NDMA is classified as a probable carcinogen (a substance which may cause cancer) based on the results of laboratory tests, the presence of NDMA was unexpected and would be related to changes in the way the active substance was manufactured. "

In the United States, the FDA also She expected that she will study the level of NDMA products called to recall and analyze the possible effects on the patients who consumed them.

In Argentina, ANMAT suggested to patients to take some of the brands and lots of valsartan that do not stop the treatments without consulting their doctor and / or pharmacist. "The suspension of the same may generate greater consequences for his health and the health professional is instructed to evaluate the appropriate alternative for each particular case and treatment," warned L & # 39; organism, that made available to patients the line ANMAT Responde (0800-333-1234) Monday to Friday from 8am to 20h and Saturdays and Sundays from 10am to 18pm, in addition to the mail responde @ anmat.gov.ar.

Along the same lines, the Argentine Cardiological Foundation (FCA) said in a statement that it is "necessary to warn that patients who take a drug containing valsartan should not stop taking until they consult their doctor, as the consequences of doing so without proper indication involve a high risk. "

" It is not a matter of alarming the population but to provide clear and precise information so that patients do not interrupt treatment until their doctor does not indicate the replacement of the drug in the necessary cases " , said Jorge Tartaglione, president of the FCA, pointed out that valsartan is not questioned as an antihypertensive and heart failure treatment, but the problem is limited to the raw material of the manufacturer. 19659002] "Multiple studies have shown their usefulness in the management of these pathologies, which has allowed the increase in survival and the reduction of morbidity and mortality. cardiovascular diseases are the leading cause of death in the country and in the world ", added Miguel Schiavone, also a member of the CAF.

Regarding the NDMA impurity, cardiologist Stella Maris Pereiro González confirms that in Argentina "this substance was classified as probable carcinogen in humans group 2A, which includes products and substances with evidence that there is likely to be a positive association between the product and the development of long-term tumors. "