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The Bulgarian Medicines Agency (BDA) announced that it had blocked the sale of dozens of drugs for high blood pressure and heart failure containing valsartan. The cause is a dangerous impurity in the active substance. The Health Fund reported that 160,600 people had to be treated by a doctor to change treatment
The sale of drugs to different manufacturers is stopped throughout the European Union as an active ingredient, manufactured by a Chinese manufacturer, found that the impurity of N-nitrosodimethylamine (NDMA) was clbadified as probable carcinogen
The Drugs Agency reported that it is a preventive measure because it is currently unclear if and in what amount the impurity in the drug spared and this is being studied by the European Medicines Agency (EMA). It is thought that the presence of carcinogenic impurity is related to changes in the manufacturing process of the Chinese manufacturer introduced in 2012. The possible impact on patients still needs to be clarified.
The sale of the medicines concerned has been suspended since Thursday in Bulgaria. The BDA publishes a list of blocked drugs as well as a list of drug alternatives
"With 62 drug products blocked, the alternatives are over 100, so there is no need for s & d. There are sufficient alternatives available from the group of sartans that can be substituted for these products.For the peace of mind of patients, they should, at the first opportunity, turn to a doctor for to instruct " explains Mary Peycheva, an expert at the BDA.
Valsartan is an angiotensin II receptor antagonist used to treat high blood pressure, recent myocardial infarction, and heart failure. It is available on the pharmaceutical market alone or in combination with other active substances
People should not stop their medication before consulting a doctor
Pharmacists are categorical: it There is no panic, people should stop taking their blood medicine before consulting a specialist. The problem has been around for some time, so it's not fatal if patients continue to use the medications in question for a few days or a week. . There is no indication that use should be stopped immediately and so there is no reason to panic and patients should not stop taking it before a new treatment by a doctor. The problem is no longer spreading this issue " said Professor Ilko Getov, president of the Bulgarian Pharmaceutical Union at Mediapool .He recalled that pharmacists do not have the right to replace prescription drugs, (19659002) "We are waiting for instructions from the NHIF on what to do with three-month prescriptions, prescriptions containing, besides blocked products and other drugs, other that those who are affected, to perform the others "explains Getov As blocked drugs are widely used, there may be reference products from the list of positive drugs, and blocking their sale may change the patient's payment
Hypertension products are usually reimbursed at 25% to 75% by the NHIF and are relatively inexpensive – between 2 and 10 levs, and the change of treatment is possible in ur the patient at a slightly higher price.
The European Medicines Agency (EMA) and the relevant national authorities, such as the BDA, have been informed of the presence of dangerous drug manufacturers impurity by the Chinese supplier Zhejiang Huahai Pharmaceuticals, who is a signatory for the problem. This is not related to the established violations of GMP compliance and it is not known if any other active substances in this company are affected, said the EMA.
EMA and national agencies are working together to investigate the degree of impurity contamination involved for drugs containing valsartan and their possible effect on patients who take them. Additional information on this study will be made available to the public as soon as it is available, announced by the BDA
. In addition, steps have been taken to reduce levels and eliminate contamination of future lots of valsartan
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