Pharmacies advised to recall valsartan products

Leslie Hanson
July 10, 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a recall yesterday (July 5) for all batches of valsartan-containing medicines made by Dexcel Pharma Ltd and Accord Healthcare following "emerging information" of an impurity identified in the manufacturing process, which "may have carcinogenic potential".

Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack, and heart failure.

The ministry added that that medication was used to threat blood pressure and cardiovascular problems.

According to worldwide media reports, the company Zhejiang Huahai found N-nitrosodimethylamine (NDMA) in the valsartan active substance supplied to manufacturers producing some of the valsartan medicines available in the European Union.

The appearance of the impurity - N-nitrosodimethylamine - follows a change in the process for making valsartan at the Chinese plant, the agency said. Not all valsartan medicines are affected by the recall. At present there is no evidence that this impurity has caused any harm to patients; however, this recall action is being undertaken as a precautionary measure to prevent any further exposure to the impurity in the affected medicines whilst the investigation is ongoing.

The Health Products Regulatory authority says patients should not stop taking medicines containing valsartan but should go to their pharmacist or doctor immediately to discuss treatment.

"The European Medicines Agency and other EU regulators are working together to investigate the extent of the issue and any possible impact for patients".

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