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The Ministry of Public Health (MSP) on Thursday issued a statement informing the preventive withdrawal of drugs containing valsartan, an active substance found in substances that treat high blood pressure, due to the detection of 39, an impurity. The MPS is studying the case of "possible associated health risk" since "active" has been used in several drug presentations. "
The document indicates that the European Medicines Agency (EMA) has announced that one of the producers of the asset valsartan found an impurity in the batches manufactured and marketed to different international companies.
In the case of our country, the Ministry of Public Health indicated that patients should see their specialist since the measure of suspension of the marketing of the product is precautionary and that the treatment should not be abandoned as it may generate negative consequences. With regard to doctors, it has been reported that they should use another alternative medication to continue the treatment of their patients. Finally, pharmacists must remove any stock of products containing valsartan
Communiqué from the Ministry of Public Health
The European Medicines Agency (EMA) recently announced that one of the manufacturers of the Valsartan active ingredient, Zhejing Huahai Pharmaceutical Co. Ltd. Channan Site, RC-317016, China, has identified the presence of an impurity in batches manufactured and marketed from various pharmaceutical companies around the world.
The presence of said impurity, N-nitrosodimethylamine (NDMA) in the active ingredient valsartan manufactured by Zhejing Huahai Pharmaceutical Co. Ltd. Channan Site, RC-317016, China, was generated as a result of a change in the manufacturing process, which is being investigated.
Valsartan is an active antagonist of the angiotensin II receptor that is used to treat high blood pressure. It is available only or in combination with other active ingredients.
In the case of our country, this raw material has been used in several presentations of
drugs that include valsartan. At present, the Ministry of Public Health assesses the possible associated health risk.
Recommendations:
- For patients: in the case of the use of any of the drugs included in the list, do not interrupt the treatment and go to your doctor the suspension of marketing is a precautionary measure. Abrupt suspension of treatment can have serious consequences for your health.
- For physicians: It is recommended to evaluate current treatments and, in the case of patients in treatment with one of the affected presentations, to replace them with another drug. the same composition that is not affected or that indicates another therapeutic alternative
- For pharmacists: check the existence in stock of affected lots, and carry out the quarantine.
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