Ongoing review of valsartan medicines reveals NDMA in medicines from second manufacturer

An ongoing review of valsartan medicines by the European Medicines Agency (EMA), has led to the detection of low level of nitrosodiumethylamine (NDMA) in medicines produced by another company, Zhejiang Tianyu.

NDMA is a substance that has been classified as a probable human carcinogen (could cause cancer). Several medicines, manufactured by Zhejiang Huahai, were recalled last month (July 2018) as a result of the detection of NDMA in the active ingredient for some valsartan medicines, however, the NDMA levels in batches of medicine from the second manufacturer are much lower.

The EMA has revealed it is working closely with international partners to review the impact of the NDMA found in valsartan from Zhejiang Tianyu and will communicate an update as soon as possible.

However, it has specified that there is no immediate risk to patients and no patient should stop taking any valsartan medicines without consulting their doctor or pharmacist. A list of medicines containing valsartan and manufactured by Zhanjiang Tianyu will be made available from national medicines authorities.