European Medicines Agency recalls generic heart medication over safety fears

The European Medicines Agency (EMA) is reviewing medicines containing the active ingredient Valsartan supplied by a facility in China, after a potentially carcinogenic impurity was detected in it.

In a statement issued by the Health ministry, it said that both the Medicines Authority and Superintendent for public health (SPH) are following the situation.

“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.

It said the authorities would continue following the situation and will advise the public accordingly.

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

“Unless another warning is issued, the Medicines Authority and the SPH are adhering to directions given by the EMA and Health Products Regulatory Authority that patients shouldn’t stop using this medication haphazardly. Further advice will be issued as the situation develops.”

According to international media reports, 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.