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The Medicines Agency (BDA) blocks 62 pharmaceuticals for the treatment of hypertension, heart attack and heart failure due to an impurity with a substance possibly carcinogenic. According to the data of the National Health Insurance Fund, the problem can affect about 160 thousand people in Bulgaria but according to the pharmacists, their number is 290 000
Mary Peycheva, Director of Legal, Administrative and Financial Activities and of Quality at BDA, notes that there is currently no information on the duration of exposure of patients to the potentially dangerous substance contained in cardiovascular drugs
The European Agency Drugs (EMA) and the relevant national authorities have been informed and the presence of an impurity in the active substance valsartan manufactured by "Zhejiang Huahai Pharmaceuticals" in China. The impurity N-nitrosodimethylamine (NDMA) is clbadified as a probable carcinogen.
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The Chinese company reported these impurities to end-user manufacturers from the European Union who use the active substance valsartan to make drugs, and they in turn reported to the regulatory authorities of the EU [19659002] European Medicines Agency and national authorities are working together to study the extent of NDMA contamination of drugs containing valsartan and their possible effects on patients who receive them
In collaboration with the manufacturer, is working to take appropriate corrective medication measures aimed at reduce levels or eliminate impurity from future lots of valsartan
Meanwhile, as a precautionary measure, BDA will block sales and withdraw ra pharmacies drugs containing the active substance a substance containing valsartan provided by Chinese society in the EU
There are many other therapeutic alternatives containing the angiotensin-II receptor antagonists on the Bulgarian Pharmaceutical Market
Patients taking drugs containing valsartan Questions about the medicines concerned should be contacted by a pharmacist and his doctor.
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