Europe recalling some valsartan meds on safety fears

There were 449,410 medicines with steroids detained in 2017 according to the Health Products Regulatory Authority

"This active substance is used in a number of medicines marketed in Europe", the regulator said.

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

"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", said Dr Sam Atkinson, MHRA's Director of the Inspection, Enforcement and Standards Division. The review was triggered after the company detected an impurity, N-nitrosodimethylamine (NDMA), a substance classified as "probable cancerogen". The figure also includes valsartan products not affected by the recall.

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.

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The medicines contain the ingredient Valsartan. The medicines are being recalled as a precaution after information emerged that an impurity.

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. The health risk of abruptly discontinuing this medicine is higher than any potential risk presented by the impurity.

In addition to working closely with the European regulatory network on the investigation, the HPRA is informing all stakeholders including the Department of Health, the Pharmaceutical Society of Ireland (PSI), the Irish College of General Practitioners (ICGP) and other healthcare professionals of this ongoing regulatory action.


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