EMA reviews valsartan drugs after detecting an impurity

| By | API, Drug Quality Control, EMA
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The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a Chinese pharma company.

The review was triggered after the company detected an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active substance which the company supplies to manufacturers producing some of the valsartan medicines available in the EU. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

While the review is underway, national authorities across the EU are recalling medicines containing valsartan supplied by Zhejiang Huahai.

Valsartan medicines are used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke. It is also used in patients who have had heart failure or a recent heart attack.

EMA’s review will 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 review will be carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP).