Thursday, 15 November, 2018

European Medicines Agency recalls generic heart medication over safety fears

Samantha Long | 08 July, 2018, 03:24

The European Medicines Agency said the recall followed identification of the impurity in the active substance valsartan manufactured by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

The company Zhejiang Huahai found N-nitrosodimethylamine (NDMA) in the valsartan active substance supplied to manufacturers producing some of the valsartan medicines available in the European Union.

A number of medicines used to treat blood pressure and heart conditions are being recalled. It is also sometimes prescribed after a heart attack.

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.

Croatia beat Russian Federation on penalties to set up England semi-final
The views expressed therein are not necessarily those of stlucianewsonline.com, its sponsors or advertisers. Russia & Croatia face off in Sochi with a place in the final four on the line.

The agency published two lists - one of medicines blocked from sale and one with alternate medicines - and advised patients to contact their doctor or pharmacist to discuss their options.

"Alternative valsartan-containing products, that are unaffected by this issue, are available in the United Kingdom".

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. "We are engaging with healthcare professionals to manage this situation". 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 HPRA will provide further updates on this matter as more information becomes available.

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