Saturday, 18 August, 2018

Precautionary recall of some Valsartan blood pressure and heart medicines

There were 449,410 medicines with steroids detained in 2017 according to the Health Products Regulatory Authority There were 449,410 medicines with steroids detained in 2017 according to the Health Products Regulatory Authority
Samantha Long | 10 July, 2018, 21:38

Bulgaria's medicines agency said on July 6 that it was suspending the sale of 62 high blood pressure and heart medications, as part of a Europe-wide recall, after a potentially harmful impurity was found in the active substance manufactured in China.

A number of medicines used to treat blood pressure and heart conditions are being recalled.

The appearance of the impurity - N-nitrosodimethylamine - follows a change in the process for making valsartan at the Chinese plant, the agency said.

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

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The HPRA says not all valsartan medicines are affected and is reassuring patients that other treatments are available.

In the United Kingdom, the MHRA said it is advising pharmacies to recall all batches of valsartan containing medicines made by Dexcel Pharma and Accord Healthcare (previously known as Actavis Group) as a precaution. National authorities in the European Union are recalling drugs containing the affected API. The medicines are being recalled as a precaution after information emerged that an impurity.

"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".

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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