Why did you ask to withdraw drugs containing valsartan?



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People taking Valsartan-containing medications as an active ingredient should NOT stop taking the medication without first talking to their doctor.

The active compound is used in drugs against high blood pressure. / Pixabay

The first to give the alert was the European Medicines Agency (EMA, for acronym in English). On July 5, the largest entity responsible for licensing drugs marketed in the European Union announced that it should begin a substantial review of all drugs containing valsartan. The reason for this decision was that Zhejian Huahai Pharmaceuticals, a Chinese company supplying the active compound, found an impurity in its product.

"The review was initiated after the company detected an impurity, N-nitrosodimethylamine (NDMA), in the active substance of valsartan.NDMA is clbadified as a probable carcinogen to humans (a substance that can 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 made, "explained publicly. EMA.

In addition, the Agency asked the national authorities of the European Union that this review is over, they will remove all drugs containing valsartan provided by Zhejiang Huagai. Valsartan is generally recommended in hypertensive patients seeking to reduce the risk of heart attack and stroke. It is also used in patients who have had heart failure or recent heart attacks.

As expected, other countries, such as Colombia, have also suggested sending a medical alert to withdraw In the country, according to an annex published by Invima, there are 36 products that contain valsartan as an active ingredient, but only ten laboratories have determined voluntary withdrawal as a preventative measure since their inputs come from Zhejian. Huahai: 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 and Winthrop Pharmaceuticals de Colombia SA

the recommendation that Invima does to people who consume drugs containing the active ingredient valsar So this is not to stop the medication without first consulting the attending physician. Also, if you do not know the manufacturer of the drug, ask your EPS for an appointment to clarify it.

For its part, Invima asks clinics, hospitals, distributors, distributors and health departments to return or change the product with the chief laboratory to examine the situation in Colombia.

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