Update on valsartan medicines following detection of impurity in active substance in Europe

Several batches of Valsartan formulations imported from China have been recalled at the European level due to possible contamination with N-nitrosodimethylamine (NDMA). The European Medicines Agency (EMA) first issued a news alert on this on July 5 with an update on July 17, 2018.

NDMA has been detected in the valsartan active substance manufactured by Zhejiang Huahai Pharmaceuticals in China. The impurity NDMA is classified as a probable human carcinogen which, based on results from laboratory tests may cause cancer with long-term use.

Over the past two weeks, national medicines authorities have been recalling medicines containing valsartan from Zhejiang Huahai, and these medicines should no longer be available in pharmacies across the EU.

While further assessment is needed, there is no immediate risk and patients taking valsartan are advised not to stop their treatments unless they have been advised to do so by their pharmacist or doctor.

Healthcare professionals should follow specific advice from national authorities concerning medicines in their country.

Further information about the review of valsartan, including the questions being addressed to companies, is available on EMA’s website (http://www.ema.europa.eu).