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AIFA withdraws drugs with valsartan

July 18, 2018

In July 2018, the Italian Medicines Agency ordered the withdrawal of more than 700 batches of medicines manufactured by several pharmaceutical companies containing the active ingredient valsartan from pharmacies and from the entire distribution chain, due to certain impurities during its production at the Zhejiang Huahai Pharmaceuticals plant at the Chuannan site in China. We talked about this issue with Dr. Maria Fazio, Head of Internal Pharmacy at Humanitas.

 

A substance of concern for carcinogens in medicinal products

 

“The substance found is N-nitrosodimethylamine (NDMA), classified as probably carcinogenic – commented Dr. Maria Fazio, head of the internal pharmacy at Humanitas – Valsartan is an angiotensin II receptor antagonist used to treat hypertension and heart failure. The Italian Medicines Agency has ordered the withdrawal of several batches of drugs based on the active ingredient valsartan because a quality defect has been found. Therefore, as a precautionary measure, the AIFA and the other European Agencies have ordered the immediate withdrawal from pharmacies and the distribution chain of all the packages concerned.

Patients are responsible for checking the medicines they buy.

 

“Patients who are treated with valsartan-based drugs should check if the medicine they are taking is on the list of medicines involved in the withdrawal as a precaution – Fazio specified – For a complete reading, please attach the document received from the company:

 

 

For the complete list, click here:

Valsartan_lists_05072018 2

 

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