Precautionary recall of some Valsartan blood pressure and heart medicines

Henrietta Strickland
July 10, 2018

Valsartan was originally developed by Novartis and the Swiss company marketed it as Diovan, but it is now off patent and is used in a number of generic medicines.

The Health Products Regulatory Authority (HPRA) has stated it is undertaking a precautionary recall of a number of specific medicines* containing the active ingredient valsartan that are used to treat blood pressure and heart conditions.

A recall is underway across Europe following recent and emerging information that an impurity has been identified as part of the manufacturing process in a valsartan active substance manufactured at one facility in China. The MHRA warned the impurity, N-nitrosodimethylamine, could have "carcinogenic potential".

The presence of the impurity was believed to be related to changes in the manufacturing process of valsartan.

Dr Sam Atkinson, MHRA director of the inspection, enforcement and standards division, said: "We will communicate the outcome of our investigations and ensure that the medicines [taken by patients] are safe".

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 Medicines and Healthcare Products Regulatory Agency (MHRA) said that patients should be switched to supplies made by other companies.

The agency's Committee for Medicinal Products for Human Use (CHMP), is reviewing the possible impact of NDMA on patients and what steps can be taken to eliminate the impurity from future batches of product.

"If you are concerned, please speak to your GP, pharmacist or other healthcare professional".

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