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18/07/2018
The State Institute for Drug Control (ŠÚKL) ordered the withdrawal from the Slovak market of medicines containing the active ingredient valsartan. This is due to the presence of undeclared impurities in the active substance. The active substance is found in drugs used to treat high blood pressure, symptomatic heart failure and for treatment after a recent heart attack.
This decision applies to all lots of Vapress, Vasopentol, Valzap and Valsartan Actavis. "Since there is no acute risk for patients taking these medications, discontinuation of treatment is not advised, however, it is necessary for these patients to visit their attending physician, who will will give another appropriate treatment, at least within a month. "
The drugs are moving to a pan-European level, and the European Medicines Agency and the European Agency for Quality Management are involved in the fight against deficiency in quality. The Authority will examine, in addition to other drugs containing the active substance valsartan, medicines containing other sartons of comparable chemical structure
The European Medicines Agency has ordered a review of drugs containing valsartan when an NDMA impurity is detected in the active substance . The State Institute for Drug Control ordered the withdrawal of all relevant lots from the market on July 4, 2018 and informed patients of the need to consult the attending physician within a specified time period. One month at the latest
in the active substance produced by Zhejiang Huahai Pharmaceuticals based in China. The company delivers the active ingredient to manufacturers throughout the European Union. The withdrawal concerns only medicines that use the active ingredient of Zhejiang Huahai Pharmaceuticals. However, other drugs containing valsartan will be considered in the assessment.
May cause cancer
NDMA is classified as possibly carcinogenic to humans (a substance which can cause cancer). The presence of NDMA was unexpected and would be related to changes in the method of manufacture of the active substance. This substance is usually present in the air or in certain foods, beverages and tobacco products. However, the requirements for safety and quality of drugs are also high, namely that the presence of the impurity is unacceptable in the long run. In the evaluation, the Committee for Medicinal Products for Human Use will examine the presence of NDMA in drugs containing valsartan, the potential impact on patients who took them and the measures to be taken to reduce or eliminate impurities future batches produced by the company. Do not drive before consulting a doctor!
The State Institute for Drug Control and the European Medicines Agency do not recommend the sudden cessation of treatment. Abrupt discontinuation of antihypertensives and discontinuation of treatment in long-term hypertensive patients present a significant risk related to safety and management of blood pressure. Immediate discontinuation of treatment may result in a sudden and sudden increase in blood pressure and life-threatening complications, such as a sudden stroke
All patients taking drugs containing valsartan are recommended ] at the latest consult a doctor for one month for setting up and managing the treatment of hypertension. Several therapies, including drugs containing valsartan, are available on the market
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valsartan
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