As part of the ongoing review of valsartan medicines, the European Medicines Agency said that low levels of N-nitrosodimethylamine (NDMA) have been detected in the valsartan active substance manufactured by a second company, Zhejiang Tianyu.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The NDMA levels detected in batches of valsartan from Zhejiang Tianyu are much lower than levels seen in the active substance from Zhejiang Huahai, which triggered a recall of several valsartan medicines in July 2018.

An earlier EMA communication had said its review would investigate the levels of NDMA in these valsartan medicines, its possible impact on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company. As a precaution, the review will also consider whether other valsartan medicines may be affected.

The EMA is working closely with international partners to review the impact of the NDMA detected in valsartan from Zhejiang Tianyu and will communicate as soon as additional information becomes available. There is no immediate risk to patients and they should not stop taking valsartan medicines without consulting their doctor.

Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack and heart failure. It is available on its own or in combination with other active substances.

The review of valsartan medicines in relation to the presence of NDMA in the active substance was triggered by the European Commission on July 5, 2018. The review report will be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

Source: EMA

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