MAY CAUSE CANCER: Some drugs containing valsartan recalled

Grant Boone
July 13, 2018

The alert comes after the watchdog issued a recall last week (July 6) for seven batches of valsartan-containing medicines made by Accord Healthcare and Dexcel Pharma Ltd, after an impurity was identified in their manufacturing process which "may have carcinogenic potential".

This recall has been issued following indications of the presence of an undesirable impurity N-nitrosodimethylamine (NDMA) in the valsartan active ingredient, which is manufactured by a facility in China.

Only some valsartan medicines in the European Union are affected and these are being recalled.

As a precautionary measure, the valsartan-containing medications are recalled on a pharmacy level. Valsartan is a medicine used for the treatment of hypertension to prevent related cardiovascular complications.

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If you are in a clinical trial with valsartan and have any questions, speak to the doctor treating you in the trial. For example, Swiss company Novartis informed the ministry that their products containing valsartan are not impacted because these products do not contain the ingredient from external suppliers. The recall order was sent to authorized agents and distributors of the recalled products with an order to quarantine all quantities of the products present within their warehouses. Patients that have had a recent heart attack or heart failure also use these drugs. It is available on its own or in combination with other active substances.

EMA and United Kingdom regulators are working together to investigate the extent of the issues and any possible impact for patients.

The review covers all medicines that contain valsartan supplied by Zhejiang Huahai Pharmaceuticals.

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