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Valsartan is an active pharmaceutical ingredient, which has been on the market for over 20 years and is used in patients with hypertension and heart failure.
Valsartan, which has proven to be a very effective and safe substance, belongs to a clbad of drugs known as angiotensin II receptor antagonists, which help to control high blood pressure.
On July 13, INVIMA issued an alert for different batches of this drug, due to the discovery of a carcinogenic potential impurity, referred to as N-nitrosodimethylamine NMDA, as the International Agency for Research on Cancer ( IARC) found in Valsartan produced by Zhejing Huahai Pharmaceutical in 2017.
Adalberto Quintero, President of the Colombian Society of Cardiology, explains that "INVIMA's health alert refers to a lot of Valsartan that was manufactured in a laboratory in China, where they modified the manufacturing process with a license issued by a European quality control organization.They changed the way of manufacturing the raw material (this raw material that they provide to many laboratories in the world), and when they followed these batches of Chinese society, they discovered that in these batches there were traces (tiny particles) of & Nbsp; a substance called N-nitrosodimethylamine, which is a substance considered to be potentially carcinogenic. "
This change in the manufacturing process explained by Mr. Quintero occurred in 2017 and, as a result of this discovery, it was decided to
In Colombia
It It should be noted that not all pharmaceutical companies that market it in Colombia have contaminated Valsartan, some manufacturers in the world do not have this problem because they have not changed the process. Manufacture.
"There should not be a widespread alarm that Valsartan is no longer consumed because it's very bad," says Dr. Quintero. "The patient should not stop the drug that he takes. It is counterproductive if a hypertensive patient or with heart failure suspends Valsartan because he will have a relapse into his illness and will have very serious and very serious consequences. You should consult your doctor and the doctor should advise the patient of the appropriate modification of another molecule of valsartan that does not present this problem. "
In our country, the batches concerned are those of the pharmaceutical companies: American Generics SAS, Genfar SA, Humax Pharmaceutical SA, Laboratoire Franco Colombiano Lafrancol SAS, MK Laboratories SAS, Lafrancol Internacional SAS, Procaps SA, Sanofi-Aventis of Colombia SA, Tecnoquímicas SA, Winthrop Pharmaceuticals of Colombia SA
The other 18 laboratories that produce Valsartan in Colombia is free of this alert
This is the case of Novartis, which sent a statement to the public in Because of the many concerns that they have received since the INVIMA alert.
"No Novartis drug marketed in Colombia is related to this situation. Diovan®, Diovan® HCT, Exforge®, Exforge® HCT or Entresto® have another source of manufacture of this active ingredient, in which this impurity is not generated, "they explained.
] The carcinogenic component
] Nitrosamines are found in foods such as bacon, hamburgers, cooked ham, sausages, barbecues, smoked meats or smoked foods.This component in large quantities is toxic and potentially Carcinogen
"N-Nitrosodimethylamine has been shown to be carcinogenic in animals and, for safety reasons, should not be used in humans. It is a substance that is also found in many hairdressing and industry products, "concludes Dr. Quintero
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