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European Medicines Agency

One extra cancer case per 5,000 patients taking varsartan, says EMA

The European Medicines Agency (EMA) has issued an update on its ongoing review of the possible health effects in patients who have taken valsartan medicines containing a potentially harmful impurity.

The impurity, N-nitrosodimethylamine (NDMA), was found in the active substance manufactured by Chinese pharmaceutical company Zhejiang Huahai Pharmaceuticals. NDMA is classified as a probable human carcinogen but is not expected to cause harm when ingested in very low levels.

The EMA said the review is being carried out by the Committee for Medicinal Products for Human Use, which will adopt the Agency’s opinion. The European Commission will then issue a final, legally binding decision applicable in all EU member states.

Following a preliminary evaluation, the EMA has estimated that there could be one extra case of cancer for every 5,000 patients taking the affected medicines at the highest valsartan dose (320mg) every day for seven years. This is based on average levels of this impurity detected in the active substance from Zhejiang Huahai Pharmaceuticals (60 parts per million).

Companies that have used the active substance from Zhejiang Huahai in their valsartan medicines are required to test the samples they hold to determine the actual NDMA levels in their final products.

The EMA said there was “no immediate risk to patients” and advised that “patients taking the affected medicines who have not yet switched to an alternative should not stop taking their medicines without consulting their doctor or pharmacist”.

Following further checks, the EMA said it will be able to provide more information on the risk the impurity may have posed for patients in the EU.

The UK product recall was issued by the Medicines and Healthcare products Regulatory Agency on 5 July 2018.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205292

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