A common blood pressure and heart drug manufactured in bulk by a Chinese company and sold worldwide may have contained an impurity linked to cancer since 2012, European regulators said on Tuesday.
The revelation that the problem likely dates back to changes in manufacturing processes at Zhejiang Huahai Pharmaceutical six years ago suggests many patients could potentially have been exposed to cancer risk.
The European Medicines Agency (EMA), which first raised the alarm over the Chinese supplied valsartan on July 5 , said it was now working to establish how long and at what levels patients might have been exposed to the impurity known as NDMA.