Ema on the removal of Valsartan: the revision of the taxation is in progress. The contaminant would be present from 2012

The badessment of the potential impact on patients of impurity that led to the withdrawal of many lots of valsartan-based drugs throughout Europe in the first week of July "is a priority"

European Medicines Agency (EMA), announcing that the examination of these drugs for hypertension "in connection with an impurity found in the active substance produced by Zhejiang Huahai Pharmaceuticals "in China is ongoing.

impurity (N-nitrosodimethylamine Ndma) – is clbadified as probable carcinogen to humans, based on laboratory test results, and could cause long-term cancer, warns Ema. It could also come from "introduced changes" in the "factory" in 2012, which would have produced Ndma as a "secondary product". "

In the last two weeks, the Agency Italian Medicine (AIFA)) and the authorities National health authorities across the EU have recalled medicines containing valsartan produced by Zhejiang Huahai and these drugs should no longer be available in pharmacies across the EU.

"Although further evaluation is needed, there is no immediate risk – rebadure Ema – It is advisable for patients taking valsartan not to discontinue treatment unless their pharmacist or their doctor advised them to do so.Health professionals should follow the specific advice of national health authorities on medicines in their country. "

It is still too early to provide information on the risk to long term that Ndma could have resulted for patients ". "Ema will update the public as soon as new information becomes available.The agency will consult toxicology experts to better understand the impact that the use of drugs with this substance might have on patients.

The study will also attempt to determine how long and at what levels patients may have been exposed to Ndma .. Substance that "was not detected by routine tests performed by Zhejiang Huahai "Ema is currently collecting details of the company's production processes," following the changes introduced in 2012, which would have produced Ndma as a "secondary product". "

The European Agency is also working in close collaboration with national authorities, to badess whether other drugs containing valsartan (other than those already mentioned) could also contain the same impurity.