Hypertension, AIFA makes arrangements for withdrawal of many different drugs

The Italian Medicines Agency 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 other European agencies ordered the immediate withdrawal of the pharmacies and the distribution chain of all the parcels concerned.

ordered the removal of several batches of drugs based on the active substance valsartan. Indeed, a lack of quality was noted and, as a precautionary measure, AIFA and the other European agencies ordered the immediate withdrawal of the pharmacies and the distribution chain from all the packaging concerned.

Valsartan is used for the treatment of high blood pressure and heart failure and in patients with cardiac infarction

Patients treated with valsartan should check whether the drug qu & # 39 they take is present in the list of medications involved in precautionary withdrawal.

Information for the Citizen
• Several drugs containing valsartan are withdrawn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 products mentioned above, consult your doctor as soon as possible to switch to other medications.
• You should not interrupt treatment without talking to your doctor. alternative treatment (with another valsartan-based drug not involved in withdrawal or with any other appropriate medication)
• If you are participating in a clinical trial with valsartan and have any doubts, contact the clinician responsible for the treatment. study.
• AIFA is collaborating 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 [19659003] Information for Physicians [19659005] • The presence of an impurity was found in the active ingredient valsartan produced by Zhejiang Huahai Pharmaceuticals, in de Chuannan, Duqiao, Linai (China) and it is currently found that the impurity is present only in the products manufactured at the site mentioned.
• The impurity is N-nitrosodimethylamine (NDMA), clbadified as potentially carcinogenic to humans, which would be present in batches of raw materials used to produce drugs containing valsartan to remove.
• For patients treated with the drugs listed above, treatment may be replaced by another valsartan or with another angiotensin II receptor antagonist
• Patients treated with related products to valsartan and hydrochlorothiazide listed in the above list may switch to treatment with other valsartan hydrochlorothiazide combination products or monocomponents, e.g. one tablet of valsartan (not listed) and one hydrochlorothiazide tablet or a combined product of hydrochlorothiazide + another angiotensin II receptor antagonist.