Aifa has available withdrawal from pharmacies of different packs of valsartan-based medicines for a quality defect. They are used for hypertension and after a heart attack

The withdrawal also in the rest of Europe. The drugs based on valsartan are used for the treatment of high blood pressure and heart failure and in patients who have suffered a heart attack. Patients treated with valsartan should check if the medications they are taking are on the list of medications involved in preventive withdrawal. HERE'S THE LIST

05 JUNE – The Italian Medicines Agency has ordered the removal of several batches of drugs based on the active substance valsartan. Indeed, a quality defect was found, that, as a precautionary measure, AIFA and the other European agencies ordered the immediate withdrawal of the pharmacies and the distribution chain of all the parcels concerned.

Medications for valsartan are used for the treatment of hypertension and heart failure and in patients who have suffered a heart attack.

Patients who are treated with valsartan-based medicines should check if the medications they are taking are on the list of medications involved in preventive withdrawal.

Go to the list of products and lots concerned

Information for the citizen
– Various drugs containing valsartan are withdrawn.
– If the medicine you are taking is not listed, you can continue treatment on a regular basis.

– If you are treated with any of the above mentioned products, consult your doctor as soon as possible to switch to other medications.
– You should not interrupt the treatment without talking to your doctor, with whom you can agree to another treatment (with another drug based on valsartan not affected by withdrawal or with another appropriate medication).
– If you are participating in a clinical trial with valsartan and you have doubts, contact the clinician responsible for the study.

AIFA is working with the European Medicines Agency (EMA) and other European agencies to badess the degree of contamination of the products concerned and to take corrective measures in the production process.

Information for doctors
– The presence of an impurity was found in the active ingredient valsartan produced by the workshop of Zhejiang Huahai Pharmaceuticals, on the Chuannan site , Duqiao, Linai (China) and it is currently apparent that the impurity is present only in the products manufactured at the aforementioned site.
– The impurity is N-nitrosodimetilamina (NDMA), clbadified as carcinogenic to humans, that would be present in batches of raw material used to produce drugs containing valsartan subject to withdrawal.
– Valsartan is an 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 drugs listed above, treatment may be replaced by another valsartan or other angiotensin II receptor antagonist.
– Patients treated with products badociated with valsartan and hydrochlorothiazide listed above may be treated with other combination products, valsartan hydrochlorothiazide or monocomponents, e.g. one tablet of valsartan (not listed) and one tablet of hydrochlorothiazide or a combined product of hydrochlorothiazide + another angiotensin II receptor antagonist

05 July 2018 [19659012] © All rights reserved

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