Regulatory Affairs

EMA recalls certain heart drugs containing valsartan over safety fears

PBR Staff Writer Published 10 July 2018

The European Medicines Agency (EMA) has recalled certain heart drugs containing valsartan across the European Union (EU) over possible contamination with a cancer-causing substance.

The agency said that the recall pertains to medicines which use valsartan supplied by China-based Zhejiang Huahai Pharmaceuticals.

It revealed that the review was launched after Zhejiang Huahai detected residues of an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active substance it produced.

The Chinese company supplies valsartan to manufacturers producing certain valsartan medicines available in the EU.

EMA said that the review to be carried out by the Committee for Medicinal Products for Human Use (CHMP) will also look into whether other valsartan medicines may be affected as a precautionary basis.

NDMA is a probable human carcinogen as per results from laboratory tests. While its presence in valsartan was not expected, it is believed to be connected with the changes in the manner the active substance was manufactured, said the EMA.

The agency, in a statement, said: “EMA’s review will investigate the levels of NDMA in these valsartan medicines, its possible impact on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.”

Valsartan, which is an angiotensin-II-receptor antagonist, is used for the treatment of high blood pressure in order to cut down complications like heart attack and stroke. It is also used for the treatment of patients who suffered heart failure or had a recent heart attack.

In another development, the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA) has advised pharmacies across the country to recall all batches of valsartan containing medicines manufactured by Dexcel Pharma and Accord Healthcare as a precaution.

MHRA inspection, enforcement and standards division director Sam Atkinson said: “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.”

In Canada as well, several valsartan containing drugs are being recalled by their manufacturers, said Health Canada.