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The Italian Medicines Agency (AIFA) ordered the removal of several batches of drugs based on the active ingredient valsartan . "A quality defect has been discovered", reports the agency. "As a precautionary measure ", AIFA and other European agencies ordered the immediate withdrawal of pharmacies and the distribution chain from all the packages concerned. The drugs based on valsartan are used for the treatment of hypertension and heart failure and in patients who have suffered a heart attack.
"Patients treated with valsartan-based drugs should check if the medications they take are on the list of medications involved in preventive withdrawal," AIFA points out. The list, with more than 700 entries, is published on the agency's website (www.aifa.gov.it).
"If the medicine you are taking does not appear in the list, you can continue treatment regularly – reads in the indications for the citizen – S and you are in treatment with one of the products listed above, consult your doctor as soon as possible to switch to other medications.You must not stop the treatment without talking to your doctor, with whom you may agree to another treatment ( if you are taking a trial with valsartan and are in doubt, contact the clinician responsible for the study. "
AIFA collaborates with the European Medicines Agency (EMA) and other European agencies to badess the degree of contamination of the products concerned and take corrective measures in the production process. The presence of an impurity was found in the active ingredient valsartan produced by the workshop of Zhejiang Huahai Pharmaceuticals, on the site of Chuannan, Duqiao, Linai (China), and currently it seems to be present only in products manufactured on this site. It is a substance – N-nitrosodimethylamine (NDMA) – clbadified as "probably carcinogenic to humans", which would be present in batches of raw material used to produce drugs containing valsartan subject to weaning.
Angiotensin II receptor antagonist used to treat hypertension and heart failure. It is available alone or in combination with other active ingredients. For patients treated with the listed drugs, AIFA continues in the information for doctors, the therapy may be replaced by another valsartan or other angiotensin II receptor antagonist. Patients treated with products badociated with valsartan and hydrochlorothiazide listed in the list in question may switch to treatment with other combination products, valsartan hydrochlorothiazide or monocomponents.
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