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Commonly prescribed heart drug is recalled in 22 countries

10 July 2018

The European Medicines Agency (EMA) is reviewing medicines containing the active ingredient Valsartan supplied by a facility in China, after a potentially carcinogenic impurity was detected in it.

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.

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These are used to treat people with high blood pressure, to reduce complications such as heart attack and stroke, and also those who have had a heart failure or a recent heart attack. This active substance is used in a number of medicines marketed in Europe.

A review underway by the European Medicines Agency (EMA) and national agencies focused on medicines containing valsartan manufactured by China's Zhejiang Huahai Pharmaceuticals, the medicines agency said.

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The impurity N-nitrosodimethylamine (NDMA) that has been found is classified as a probable carcinogen.

According to Dr Lorraine Nolan, Chief Executive, HPRA, this is an emerging situation being managed in real time by the HPRA working with the European network of medicine regulators in order to determine the extent of the issue. Not all valsartan medicines are affected by the recall. The Medicines and Healthcare Products Regulatory Agency (MHRA) said that patients should be switched to supplies made by other companies.

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"If you are taking any of the affected valsartan products, it is vital that you do not stop taking your medication but you should get in touch with a doctor or healthcare professional as soon as possible".

Commonly prescribed heart drug is recalled in 22 countries