Carcinogenic contamination: European reminder of special hypertensives with valsartan

The reason for the product warning is the contamination of the active substance by an optionally carcinogenic substance.

Berlin | The Federal Institute of Drugs and Medical Devices (BfArM) informs in a press release that there is a batch recall of drugs containing valsartan in the European Union. Specifically, it is funds whose active ingredient has been manufactured by the Chinese manufacturer Zhejiang Huahai Pharmaceutical. Valsartanhaltige drugs are used for the treatment of hypertension, so the BfArM.

Reason for the recall was a contamination related to the production of the drug with N-nitrosodimethylamine. The International Agency for Research on Cancer of the WHO and the EU clbadifies this substance as "probably carcinogenic to humans".

Up to now, it is not clear if and in what concentrations the contamination is contained in the drugs. Therefore, as a precaution, all affected batches would be recalled.

More drugs affected?

A first scientific badessment of the danger potential has already taken place at European level, the statement said. Further investigation is still ongoing. The European Medicines Agency (EMA) is now voting on how to proceed with the Member States and is also studying whether other drugs may be affected, such as those containing chemically related active substances.

Patients taking drugs containing valsartan should not discontinue treatment without consulting their physician, warns the Federal Institute. Because the risk of weaning for health could be several times greater than the possible risk of a contaminated product. During this time, there is no acute patient risk.