European Medicines Agency recalls generic heart medication over safety fears

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Widely taken blood pressure drug valsartan recalled | News

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.

The impurity is due to a change in the manufacturing process at one facility in China that supplied the manufacturers with the active ingredient - used to treat high blood pressure and heart conditions - the watchdog said.

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

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.

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According to global 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.

The HPRA advises patients not to stop taking these important medicines but to go to their pharmacist or doctor at an early opportunity to discuss their treatment. The figure also includes valsartan products not affected by the recall. The MHRA warned the impurity, N-nitrosodimethylamine, could have "carcinogenic potential".

National authorities across the European Union are now recalling medicines containing valsartan supplied by Zhejiang Huahai while a review investigating levels of NDMA is undertaken. At this time, a precautionary recall of implicated products is the most appropriate action to protect patient health.

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