Widely taken blood pressure drug valsartan recalled

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A number of high blood pressure and heart drugs containing an ingredient made in China are being recalled across Europe after an impurity that may cause cancer was found in them, officials said on Thursday.

On July 5, 2018, the European Medicines Agency announced that it was reviewing products containing the API valsartan supplied by Zhejiang Huahai Pharmaceuticals in Linhai, China after N-nitrosodimethylamine (NDMA) was detected by the company.

The ministry called on medicine distributors and pharmacies to stop selling all valsartan-based medicines, including VALSARTAN WIN 80 mg and 160 mg, CO-VALSARTAN WIN 80 mg/12.5mg and 16 mg/25 mg and ATENSIL 40 mg, 80 mg and 160 mg.

Sam Atkinson, MHRA's director of the Inspection, Enforcement and Standards Division, said: "People taking valsartan medication affected by this recall are advised to not stop taking their medication, but to speak to their doctor or healthcare professional who can advise on alternative treatment".

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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.

National authorities across the European Union are now recalling medicines containing valsartan supplied by Zhejiang Huahai while a review investigating levels of NDMA is undertaken. The medication is also used by patients who have had heart disease or a recent heart attack. The health risk of abruptly discontinuing this medicine is higher than any potential risk presented by the impurity.

Patients should contact their pharmacist at an early opportunity for further advice.

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