Widely taken blood pressure drug valsartan recalled

10 July, 2018, 21:37 | Author: Sherman Richardson
  • A change in manufacturing process at a Chinese factory is thought to have led to some packs of valtarsan being contaminated with a carcinogenic substance

"In the last few hours the EMA sent a notification regarding a potential unexpected impurity found in the active pharmaceutical ingredient manufactured in China, and which is used in the manufacture of some Valsartan products", read the statement.

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.

The Medicines and Healthcare products Regulatory Agency (MHRA) has urged pharmacies in the United Kingdom to recall all batches of valsartan medicines as a precaution amid fears that an impurity compromised the manufacturing process at a facility in China.

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The impurity was identified in relation to the manufacturing process in a valsartan active substance. Not all valsartan medicines are affected by the recall. The review was triggered after the company detected an impurity, N-nitrosodimethylamine (NDMA), a substance classified as "probable cancerogen". National authorities in the European Union are recalling drugs containing the affected API. The Medicines and Healthcare Products Regulatory Agency (MHRA) said that patients should be switched to supplies made by other companies.

It added that patients should not stop taking their medications abruptly.

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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